Role Description Avec un budget de 2 milliards d’euros et 4600 agents, la Région Bourgogne-Franche-Comté est une collectivité territoriale engagée au service de ses habitants, ses acteurs économiques et associatifs, et partenaires privilégiées des collectivités de son territoire. Pour les soutenir au quotidien dans leur action, la Région conduit une politique ambitieuse en matière de gestion et d’attribution de fonds européens. Sa Direction Europe et Rayonnement International (DERI) constitue un acteur central du développement territorial, avec la gestion de plusieurs programmes européens majeurs et l’animation de partenariats à l’échelle européenne et internationale. La direction joue un rôle transversal majeur au sein de l’administration régionale, en articulation étroite avec les directions métiers et les nombreux partenaires publics, économiques et associatifs du territoire. Composée de 120 agents répartis en six services et deux antennes, la direction est implantée sur quatre sites : Besançon, Dijon, Paris et Mayence. Elle pilote la mise en œuvre de près de 740 M€ de crédits européens sur la période 2021-2027, soit l’équivalent de près d’un quart du budget régional en capacité d’action, mobilisant notamment le Fonds Européen de Développement Régional (FEDER), le Fonds Social Européen (FSE), le Fonds Européen Agricole pour le Développement Rural (FEADER) ainsi que le programme de coopération transfrontalière INTERREG France-Suisse. Consultez le détail complet de l'offre sur la page ici ou en cliquant sur le bouton "Postuler sur le site employeur". Qualifications - Cadre dirigeant·e confirmé·e avec une solide expérience dans la conduite de politiques publiques européennes. - Excellente connaissance des fonds européens et des mécanismes de programmation financière associés. - Maîtrise des enjeux institutionnels, politiques et administratifs liés à l’action européenne des collectivités territoriales. - Manageuse ou manager expérimenté·e capable de challenger des équipes d’experts. - Capacité d’animer des équipes réparties sur plusieurs sites et de favoriser les coopérations entre services. Requirements - Doté.e d’une forte capacité d’analyse et de synthèse. - Capacité à conseiller les élus et la direction générale dans la prise de décision stratégique. - Diplomate avec un excellent relationnel, capable de construire des compromis et développer des partenariats. - Représentation de la collectivité auprès d’interlocuteurs institutionnels de haut niveau. Benefits - Poste basé à Dijon ou Besançon ; déplacements hebdomadaires sur les deux sites et réguliers au sein du territoire régional, à Paris et Bruxelles. - Ouvert aux agents titulaires des grades d'attaché principal, attaché hors classe, directeur, administrateur, administrateur hors classe, ingénieur principal, ingénieur hors classe, ingénieur en chef et ingénieur en chef hors classe ou lauréats d'un des concours correspondants, ou, à défaut par voie contractuelle.

• Provide regulatory strategy advice and support the development and execution of regulatory strategies and plans • Ensure regulatory milestones are met to support approval strategies and overall business goals of the company • Plan, prepare and/or review submissions to regulatory authorities including FDA, EMA and other regulatory authorities to support the conduct of clinical trials and approval of marketing applications (e.g., IND, CTA, NDA/BLA, MAA) • Plan, author and/or review nonclinical and clinical study documents, including but not limited to: Clinical Study Protocols, Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), nonclinical and clinical summaries and scientific publications • Plan, author and/or review chemistry, manufacturing and controls (CMC) documents, including but not limited to: CMC sections of regulatory applications as well as supporting records summarizing manufacturing process development and validation, analytical method development and validation, comparability study protocols and reports, stability study protocols and reports and justification of shelf-life/expiry dating • Ensure that regulatory documents are accurate, complete and verifiable and confirm compliance with regulatory requirements and conformance to the company quality standards • Track progress of regulatory deliverables against timelines, proactively communicate progress and issues to key stakeholders and support development of proactive mitigation plans for identified risks • Collaborate with vendors who support regulatory operations-related tasks • Assist with developing and maintaining regulatory document processing and regulatory submission publishing standards and procedures • Identify and communicate regulatory system enhancement needs or technical issues • Assist with regulatory inspection activities, as necessary.

Assist in assessing and monitoring the Information Security Program by conducting risk assessments, delivering compliance training, and identifying vendor-related risks while ensuring adherence to applicable privacy laws and security standards.

Title: Regulatory Specialist Location: Lake Zurich United States Job Description: time type Full time job requisition id R-01021946 Job Summary The Regulatory Specialist reports to the Senior Manager, Regulatory Affairs. The Regulatory Specialist is responsible for the on-time filing of high-quality regulatory submissions and for post-approval maintenance of regulatory dossiers. Interacts with project teams and regulatory agencies in relation to submissions and other relevant topics. Trains new regulatory specialists. This position has no direct reports. Rate of Pay: $100,706.01 to $110,422.12 USD Annual Responsibilities Duties: - Represent Regulatory Affairs Dept. on project teams and provide regulatory guidance to clearly and convincingly communicate complex issues as well as share expert knowledge of complex issues (15%). - Review technical documents for cGMP and regulatory compliance (10%). - Serve as an expert in technical areas in dealing with development and manufacturing organizations in U.S. and abroad (5%). - Prepare and file high-quality submissions to regulatory authorities including A/NDA’s, Supplements, Amendments, Annual Reports and DMF Updates (25%). Communicate importance of quality assurance (5%). - Develop regulatory strategy for difficult issues which could significantly impact project timelines and costs (5%). - Provide regulatory decisions with regard to acceptability of submission documents and decisions (10%). - File all applications in accordance with predetermined timelines (15%). - Share with others best practices for planning, organization and time management (5%). - Function as a Special Projects Manager to support COO office on priorities, including project management, communications material development (5%). Work from office 3 days per week and 2 days per week remote. Requirements: - Must have a Bachelor’s degree in Chemistry, Biochemistry, Biology, Biotechnology or related field and one (1) year of experience in pharmaceutical regulatory affairs or other scientific area supporting pharmaceutical regulatory affairs. - Must also possess the following: demonstrated expertise preparing and filing complete A/NDAs, Supplements, Amendments and Annual Reports to FDA; demonstrated expertise successfully completing supplements and/or amendments approved by the FDA; and, demonstrated expertise understanding CFR, FDA/ICH guidelines and cGMP’s, as they pertain to pharmaceuticals. Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.