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Director of Global Regulatory Policy and Intelligence
1 month ago
Organon is seeking a highly skilled and experienced Director of Global Regulatory Policy and Intelligence to lead our Regulatory Policy and Intelligence activities. This role will be responsible for providing global regulatory policy and intelligence insights to the organization and guiding product development strategy for our research and development (R&D) portfolio.
Responsibilities- Develop and implement global regulatory policy and intelligence strategies to support product development and commercialization.
- Provide expert advice and guidance on regulatory policy and intelligence matters to senior leadership and cross-functional teams.
- Represent Organon at key meetings and discussions on regulatory policy related to our R&D portfolio.
- Champion policy initiatives important to Organon with external partners, including regulatory authorities.
- Oversee regulatory intelligence activities and identify pertinent information to disseminate to senior leadership for further action.
- Collaborate with other R&D departments, commercial organization, and manufacturing organizations to drive innovative and creative solutions for achieving R&D goals and objectives.
- M.S., M.D., or PhD in biological science, chemistry, or related discipline, or PharmD with 5-10 years' experience in the 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.
- Strong communication and negotiation skills, with the ability to build effective working relationships with regulators and other stakeholders.
- Demonstrated collaboration with national and international stakeholders to promote convergence in both policy and strategy in the assessment of medicinal products/devices worldwide.
- Knowledgeable and active in strategic regulatory initiatives and the application of emerging technologies to support global regulatory harmonization and convergence.
Organon is a global healthcare company focused on making a world of difference for women, their families, and the communities they care for. We have a diverse and trusted portfolio of health solutions and are 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.
