Director of Global Regulatory Policy and Intelligence
4 weeks ago
Job Title: Director, Global Regulatory Policy and Intelligence
Job Summary:
Organon is seeking a highly skilled and experienced Director, Global Regulatory Policy and Intelligence to lead our Regulatory Policy and Intelligence activities. This role will be responsible for providing strategic guidance and support to our Global Regulatory Affairs team, as well as representing Organon at key meetings and discussions related to regulatory policy.
Key Responsibilities:
- Develop and implement strategic policy priorities and initiatives to support Organon's global regulatory affairs goals.
- Provide expert advice and guidance on regulatory policy and intelligence matters to internal stakeholders, including senior leadership and cross-functional teams.
- Represent Organon at key meetings and discussions with regulatory authorities, industry associations, and other stakeholders to promote Organon's interests and influence regulatory policy.
- Oversee the development and implementation of regulatory intelligence activities, including monitoring and analyzing regulatory trends and developments.
- Collaborate with internal teams, including R&D, commercial, and manufacturing, to ensure alignment and effective communication on regulatory policy and intelligence matters.
- Stay up-to-date on emerging regulatory trends and technologies, including artificial intelligence and machine learning, and identify opportunities to leverage these technologies to support Organon's regulatory affairs goals.
Requirements:
- M.S., M.D. or PhD in biological science, chemistry or related discipline, or PharmD. with 5-10 years' experience in Pharmaceutical Industry or Academia.
- Regulatory Policy and Intelligence Professional with a proven track record of influencing International Regulatory thought process and guidance development.
- Experience in developing strategic policy priorities and implementation of these priorities globally in conjunction with internal teams and external entities.
- Experience in building effective working relationships with regulators.
- Demonstrated collaboration with national and international stakeholders to promote convergence in both policy and strategy in the assessment of medicinal products/devices worldwide.
- Long-standing involvement with key international trade associations and consortia such as Biotechnology Innovation Organization (BIO), Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA).
- Knowledgeable and active in strategic regulatory initiatives and the application of emerging technologies (e.g., artificial intelligence, machine learning, regulatory cloud) to support global regulatory harmonization and convergence.
- Outstanding interpersonal, communication and negotiation skills.
- Demonstrate sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations.
About Organon:
Organon is a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.
Equal Employment Opportunity:
Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.
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