Director, Regulatory Policy & Intelligence

Overview Leading the Regulatory Policy and Intelligence activities for Global Regulatory Affairs covering all Therapeutic Areas and products, as well as all countries or regions of interest to Organon.

Responsibilities Provide Global Regulatory Policy and Intelligence insights to the organization to guide product development, and geographical expansion strategies for R&D portfolio including new Business Development opportunities.

Identify key Regulatory Policy areas that Organon should focus on and propose initiatives.

Represent Organon at key meetings and discussions on Regulatory Policy related to R&D portfolio and Business Development projects.

Champion policy initiatives important to Organon with external partners, notably with regulatory authorities.

Oversee Regulatory Intelligence activities and identify pertinent information to disseminate to senior leadership for further action.

Establish an international regulatory intelligence and policy network to ensure compliance with local regulatory requirements (where applicable) and to gather information from the international regions or countries of interests to Organon.

As part of GRS extended leadership team, participate in projects and initiatives outside of primary responsibilities as needed to drive the organization forward to success.

Work seamlessly with the broader Regulatory division, R&D departments as well as commercial organization and manufacturing organizations.

Leveraging new technologies where possible, drive innovative and creative solutions for achieving R&D goals and objectives in a high quality and cost-effective manner.

Required Education, Experience and Skills M.S., M.D. or PhD in biological science, chemistry or related discipline, or PharmD. with at least five 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.

Experienced 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.

Location Preferably North America or EU

Ability to travel globally as required.

Some flexibility with regards to hybrid working arrangements.

Secondary Language(s) Job Description Who We Are :

Organon delivers ingenious health solutions that enable people to live their best lives. We are 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. Our Vision is clear : A better and healthier every day for every woman.

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Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted 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.

Applicable to United States Positions Only : Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into