Job Title
The successful candidate will lead Regulatory Policy and Intelligence activities for Global Regulatory Affairs, covering all Therapeutic Areas and products worldwide.
Main Responsibilities:
* Provide Global Regulatory Policy and Intelligence insights to the organization and guide product development strategy for research and development (R&D) portfolio.
* 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.
* 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.
* Collaborate with other departments as well as commercial organization and manufacturing organizations.
* Drive innovative solutions for achieving R&D goals and objectives in a high-quality and cost-effective manner.
Required Qualifications:
* 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.
* Knowledgeable and active in strategic regulatory initiatives and the application of emerging technologies.
* Outstanding interpersonal, communication and negotiation skills.
About Organon:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a global healthcare company focused on making a world of difference for women, their families and the communities they care for.