Regulatory Associate (EU mkt, CMC module 3) Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities JOB RESPONSIBILITIES - Should have minimum 6 months to 2 years of experience - Candidates with internship preferred - Should have CMC experience in small molecule. - Markets experience in EU, GCC, APAC would be preferred - Essential Functions - Assists with preparation of product development documents including gap analyses and clinical development plans. - Assists with preparation of regulatory submission documents including components of investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities, according to current government regulations and guidelines. - Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests. - Performs quality checks on related documents. - Assists with submissions of other regulatory documents and other regulatory research as needed. - Assists clients, customers, or others with general information - Gathers, compiles, analyzes, and reports information. - Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence. QUALIFICATION REQUIREMENTS - Excellent interpersonal / communication skills. - Advanced skills in Microsoft Office Applications. - Good time and project management skills, preferred. - Strong analytical skills and attention to detail. - Ability to work both as a team member and independently and to understand and carry out detailed instructions. - Ability to interact with staff from multiple departments. - Ability to work concurrently on projects, each with specific instructions that may differ from project to project preferred. - Fluent in speaking, writing, and reading English. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Role Description Au sein de l'unité politique sociale du logement, vous êtes chargé(e) de piloter et animer l'unité, de garantir le rôle de l'État dans la gestion locale des attributions et coordonner l'ensemble des réflexions en matière d'accès au logement social sur le territoire, de mettre en oeuvre les politiques sociales du logement en lien avec la DEETS : la prévention des expulsions locatives, le relogement des publics prioritaires, le DALO. Vous effectuez ces missions en veillant au respect des délais d'instruction et des procédures. Vos actions contribuent à la lutte contre l'exclusion sociale. - Piloter et animer l'équipe, afin de contribuer à la cohésion de l'unité PSL; - Élaborer, mettre en oeuvre et coordonner le plan territorial d'action pour le logement et l'hébergement des personnes défavorisées (PTALHPD), en lien avec la CTM; - Mettre en oeuvre les politiques sociales du logement et les réformes y afférentes; - Veiller à la mise en oeuvre du droit au logement; - Piloter l'unité dans les domaines de l'attribution des logements sociaux (contingent de l'État), du DALO et de la prévention des expulsions locatives; - Veiller à la qualité de l'accueil du public (téléphonique et physique); - Assurer le suivi des activités des bailleurs en matière d'attribution de logements (gestion en flux); - Accompagner les collectivités dans l'élaboration des Conférences Intercommunales du Logement (CIL) et des plans partenariaux de la gestion de la demande; - Coordonner et animer la CCAPEX; - Représenter la DEAL aux différentes réunions; - Veiller à la production des tableaux de bord et des statistiques de l'unité. Qualifications - Connaissance de l'environnement professionnel, notamment celui du service et des acteurs du logement; - Connaissance des politiques locales de l'habitat et des politiques sociales du logement; - Connaissances juridiques de base; - Connaissance de la réglementation relative au DALO et à la PEX; - Connaître les techniques d'accueil du public; - Maîtriser les outils bureautiques. Requirements - Savoir manager; - Savoir animer une réunion, un réseau; - Savoir rédiger des courriers et des PV de réunion; - Avoir l'esprit de synthèse, d'analyse et être force de proposition; - Faire preuve de rigueur et de méthode; - Faire preuve de capacité d'initiative, d'adaptation et de réactivité; - Être autonome; - Savoir respecter les délais; - Faire preuve de rigueur et de méthode. Benefits - Savoir travailler en équipe; - Savoir accueillir, écouter et communiquer avec amabilité et courtoisie; - Faire preuve de discrétion et de disponibilité; - Avoir le sens et le goût du contact; - Savoir s'exprimer à l'oral devant un public; - Être à l'écoute; - Obligation de discrétion et de confidentialité. Éléments de candidature - Documents à transmettre : Pour postuler à cette offre, l'envoi du CV et d'une lettre de motivation est obligatoire; - Personnes à contacter : bernard.planchet@developpement-durable.gouv.fr, cyrille.liroy@developpement-durable.gouv.fr.

Senior Regulatory Affairs Specialist Location: Sarasota, FL; Charlotte, NC; Milford, DE; or York, PA, United States Job Description: Company: Dentsply Sirona, Inc Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona's products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona's global headquarters is located in Charlotte, North Carolina. The company's shares are listed in the United States on NASDAQ under the symbol XRAY. Bringing out the best in people As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we're looking for the best to join us. Working at Dentsply Sirona you are able to: Develop faster - with our commitment to the best professional development. Perform better - as part of a high-performance, empowering culture. Shape an industry - with a market leader that continues to drive innovation. Make a difference -by helping improve oral health worldwide. This position can be a hybrid working arrangement for someone that is near one of the following Dentsply Sirona locations: Sarasota, FL; Charlotte, NC; Milford, DE; or York, PA. Job Summary: The Senior Regulatory Specialist is a contributing member of cross-functional teams in support of regulatory market access activities for US, Canada, EU, and other countries. May support NPD and Sustaining activities for the US, Canada and EU markets. Also supports additional international registrations. Key Responsibilities: - Assists in development and execution of regulatory strategies to obtain and maintain regulatory approvals for medical devices - Prepares and submits international regulatory submissions to obtain and maintain regulatory approvals for medical devices, including 510(k) submissions and technical files for CE Marking - Maintains regulatory files and databases to ensure compliance with regulatory requirements - Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle - Participates in review of labelling and claims for the US and EU markets. - Reviews and interprets regulatory requirements and guidance documents to ensure compliance - Coordinates regulatory activities with internal teams and external regulatory agencies - Supports regulatory audits and inspections as SME for questions related to market access - Stays current with regulatory requirements and updates affecting medical devices - Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships - Complies with company and departmental policies and administrative requirements - Performs other duties as assigned or as needed Education: - Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline Years and Type of Experience: - 5(+) years of experience in regulatory affairs, preferably in the medical device industry - Experience with leading regulatory submissions and documentation, including 510(k) submissions and CE marking - In-depth knowledge of FDA regulations and international standards (e.g., ISO 13485, MDSAP, EU MDR) Required Computer / Software Skills: - Proficiency with Microsoft Office Suite - Proficiency with Regulatory software Key Required Skills, Knowledge, and Capabilities: - Strong attention to detail and organizational skills - Excellent communication (both written and verbal) and interpersonal skills - Ability to work effectively in a team environment - Knowledge of regulatory affairs principles and practices - Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported - Willingness to learn and adapt to new processes and technologies - Regulatory registration experience within med device organizations - Prior technical writing experience and proven track record with FDA and EU regulatory submissions preferred. Dentsply Sirona is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona. For California Residents: We may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes). The above categories of personal information are collected for the following business purposes: performing recruitment and hiring services; processing interactions and transactions (e.g., to comply with federal and state laws requiring us to maintain certain records, managing the workforce); and security (e.g., detecting security incidents, protecting against fraudulent or illegal activity).

Role Description This is a working account manager role where the account manager is required to work alongside the rest of the team. This is not solely a management role. The Account Manager will work closely with the Director of Global Trade Services & VP of Global Trade Services to deliver client-related solutions and services specified within the scope of the client’s SOW. Serve as an extension of our client’s team or organization and ensure compliance per our client’s established policies, procedures and risk tolerance, while adhering to Vigilant’s core values. Ensure the team’s highest level of quality while maximizing bottom-line profit. Primary Job Responsibilities - Serve as the client’s primary point of contact for all communications and account activities. - Classification of client products with their respective Worldwide ECCN & HTS/HS classifications as defined by the SOW. - Research and identify possible PGA and FTA requirements for the client products. - Responsible for the daily management and delivery of all solutions and services specified within the scope of a Managed Services Program and adherence to service level agreements (SLAs). - Responsible for communicating the request to perform any support request outside the scope of a Managed Services Program or Project to the Director of Global Trade Services &/or VP of Client Success. - Ensure tracking of all relevant Key Performance Indicators (KPIs). - Provide weekly and monthly operational updates as specified by Director of Global Trade Services & VP of Client Success. - Responsible for coordinating, preparing and delivering Quarterly Business Reviews as specified by Director of Global Trade Services & VP of Client Success. - Perform and ensure the highest level of quality in the delivery of services to the client through Weekly, Monthly and Quarterly audits of the team’s work. - Other duties as assigned or required by the client specific SOW. Other Representative Job Duties - Manage overall change control processes, perform audits and quality assurance as specified by VP of Global Trade Services to ensure client and employee satisfaction. - Ensure work product is at the highest level of accuracy and timeliness. - Proactively follow-up with clients to monitor effectiveness of team performance. - Participate in scheduling, recruiting, mentoring, training, hiring and firing of team members. - Responsible for the accurate and timely submission of daily hours for all team members. - Responsible for learning and leveraging technology in the delivery of all solutions and services specified within the scope of the Project/Program. - Responsible for monitoring and responding to client and Vigilant emails in a timely manner. - Responsible for answering and responding to client and Vigilant cell phone calls in a timely manner. - Ensure the optimal and efficient allocation of resources to maximize profitability while ensuring client satisfaction. - Develop and implement personal and team Back-Up/Disaster Recovery plans. - Oversee cross-training of team to increase compliance skills. - Responsible for assisting on other client projects (bandwidth permitting) and providing back-up for other client accounts. - Review/audit import and export transactions to ensure accuracy and compliance with the various regulations. - Responsible for executing Export and Import controls as directed by the Client’s Policies, Processes and Procedures. - Identify on a timely basis all account challenges, while providing strategies and approaches to overcome these barriers/challenges. - Ensure the timely and accurate completion of projects, within budget. - Proactively analyze client/account data to identify opportunities for operational improvements. - Develop and implement new processes and procedures to improve operational efficiency. - Identify opportunities to offer additional solutions to client based on need or value. - Identify opportunities to offer new services, solutions or technology to Vigilant clients. Qualifications - Bachelor’s Degree required, preferably in Business or other related field. - Minimum 7 years’ experience in a corporate trade compliance, customs broker or compliance consulting environment. - Advanced knowledge of import and export trade compliance processes, policies and controls. - Excellent analytical and organizational skills with the ability to perform the day-to-day account activities independently with minimal supervision. - Demonstrated ability to organize and prioritize work in a dynamic and complex environment to meet deadlines and daily requirements. - Demonstrated ability to work cross-functionally with Legal, Sales, Operations, Logistics, Engineering, Finance and IT executives to achieve clients’ business and compliance objectives. - Demonstrated ability to communicate (verbally and written) effectively with clients, coworkers, and leadership. - Demonstrated leadership skills such as conflict/issue resolution, strong client interfacing skills. - Demonstrated professional knowledge of Microsoft Office (Word, Excel, Power Point). - Customs Brokers License preferred, professional certificates, licenses, and training experience a plus. Benefits - Company offers health insurance with Health Savings Account (HSA) & Flexible Spending Account (FSA). - Vision, dental & supplemental insurance plans. - Company paid STD, LTD, Life Insurance/AD&D. - Employee Assistance Program (EAP) and Employee Perks Program. - 401K plan with company match.