Role Description Responsible for our development programs from preclinical candidate designation through drug approval. Provide regulatory leadership and guidance to project teams and work collaboratively with cross-functional team members, vendors and consultants to identify optimal and effective regulatory strategies for assigned projects. - Develop and implement regulatory strategies for clinical development programs in alignment with corporate objectives and regulatory requirements. - Offer regulatory considerations for the design, conduct, and interpretation of clinical trials. - Identify and assess regulatory risks associated with development programs and define strategies to mitigate risks. - Stay informed of emerging regulatory trends, guidance documents, and best practices related to clinical development and regulatory affairs. - Prepare and lead teams through successful regulatory meetings and interactions. - Lead the authoring, review and editing of high-quality, compliant regulatory documents according to specified timelines and goals. - Provide insight and guidance on the implementation of current regulations and assess regulatory risk based on precedence. - Mentor and develop the Regulatory Affairs team, fostering a culture of continuous improvement and excellence. - Lead inspection readiness activities, including the preparation and coordination of mock and actual inspections. - Contribute to the development and maintenance of Regulatory Affairs Department working practices and procedures. Qualifications - Must have at least 2 years of prior work experience in each of the following: - Supported development programs, provided regulatory expertise and support for development project work including regulatory review for clinical study teams, regulatory submissions and processes. - Led efforts for coordinating content and publishing documents for INDs, Clinical Trial Applications and NDA/MAA, and their associated maintenance. - Led the Regulatory Submission Teams, designed programs for complete and accurate IND/CTA submissions, and ensured that clinical trials are designed to meet regulatory requirements. - Provided regulatory input for clinical development documents e.g., Investigator Brochures, annual Reports and DSURs, Safety Reports, Orphan Drug Application. - Extensive submissions experience at the IND, CTA and NDA/BLA/MAA stages. - Thorough understanding of drug laws such as Federal Food, Drug, and Cosmetic Act of 1938, Orphan Drug Act of 1983, FDA Amendments Act (FDAAA) of 2007, FDA Safety and Innovation Act (FDASIA), 21st Century Cures Act, Directive 2001/83/EC, Directive 2010/84/EU, Directive 2001/20/EC, Regulation (EC) No 726/2004 etc. - Thorough understanding global regulations and requirements such as International Council for Harmonization (ICH) guidelines, FDA/EMA regulations and guidance, etc. - Must hold Regulatory Affairs Certification (RAC) Requirements - Master’s or foreign equivalent in Regulatory Science, Pharmacy, Life Sciences, or related field - 10 years of experience in job offered or related occupation Benefits - Telecommuting allowed for this position Company Description This notice is being provided as a result of the filing of an application for permanent alien labor certification for this relevant job opportunity. Any person may provide documentary evidence bearing on the application to the Certifying Officer, U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification, 200 Constitution Avenue NW, Room N-5311, Washington, DC 20210.

• Support the development and implementation of the Company’s Healthcare Compliance Program in France • Collaborate with internal teams to identify required regulatory submissions • Deliver training to teams on regulatory submission processes • Provide advice and guidance on healthcare compliance matters

• Act as the local compliance officer for Germany • Support development of Healthcare Compliance Program • Collaborate with internal teams to ensure compliance with regulations • Conduct monitoring and auditing of compliance policies • Provide training on compliance matters

Role Description - Communication - Understand the purpose and role of communications in the wider therapy area and commercial landscape. - Demonstrate the ability to communicate clearly to different audiences through a variety of media (print and digital). - Identify and communicate important therapy area updates and any medical/regulatory milestones to the team and clients where appropriate, linking this with any potential new business opportunities where applicable. - Provide regular feedback to junior teams across accounts and projects. - Ensure regular status updates to senior team members on accounts and projects, including being able to clearly escalate anticipated challenges/needs in a timely manner. - Project Delivery - Able to work across multiple projects and accounts simultaneously, whilst monitoring team output. - Demonstrate a thorough understanding of timelines, budgetary constraints and scopes of work. - Adhere to the quality control process and ensure all work produced by the team has gone through the correct internal review process, setting the example for junior team members to follow. - Demonstrate a good understanding of project management and resource planning. - Maintain a working knowledge of pharmaceutical industry standards and compliance. - Enter time and submit expenses by the deadlines set, using appropriate job codes. - Scientifically Savvy - Independently produce consistently high-level content. - Independently and accurately incorporate strategic concepts into projects. - Lead and develop content with minimal review/direction, including data understanding and ability to communicate to a wide range of complex projects. - Become a scientific expert in your allocated therapy areas, sharing your knowledge within the agency and with clients where appropriate. - Lead and take responsibility for client review meetings, and demonstrate the ability to present and be comfortable with the interrogation of your work. - Business Development - Work with relevant project teams to help develop project proposals and input on budgets. - Attend pitches as required. - Collaboration and Building Relationships - Build effective relationships with external suppliers, key opinion leaders and medical experts to help develop high-quality content. - Establish and maintain excellent working relationships within and across departments, attending and proactively contributing to briefing/internal discussions. - Independently lead written and verbal client communications. - Demonstrate a thorough understanding of business offerings, identifying opportunities for account growth and cross-selling. - Proactively address and manage any conflicts that arise. - Developing Talent - Oversee the work of and provide clear direction to junior scientific services colleagues, delegating responsibilities and tasks where appropriate to provide experience, growth and knowledge transfer. - Review copy and provide helpful and clear constructive feedback to junior team members. - Assist junior team members with interpreting external feedback and applying learnings. - Help guide junior team members in their own strategic development by clearly explaining how to incorporate strategic concepts into projects. - Assist junior team members in identifying tasks and responsibilities that need to be prioritised and explaining the rationale. - Provide effective line management, and supervise and support your team to help them achieve their objectives. - Taking the Initiative - Ask team members (across all levels) for feedback, and proactively implement learnings. - Own responsibility for your personal development, regularly looking for other ways to learn and grow professionally by maximising exposure to new opportunities, making the most of training and requesting training as required. - Undertake tasks outside of the specifics of the job description where business reasons require it. Company Description Omnicom Health is committed to hiring and developing exceptional talent. We agree that talent is uniquely distributed, and we’re focused on developing inclusive teams that can bring the best solutions to everything we do. We strongly believe that celebrating what makes us different makes us better together. Join us—we look forward to getting to know you. We will process your personal data in accordance with our Recruitment Privacy Notice.