Director, Global Regulatory Strategy - Biosimilars

Job Description

The Position

The successful candidate will work with alliance partners and internal cross-functional project teams in the development and implementation of world-wide regulatory strategies for their assigned biosimilar projects. This may include assets in all phases of development through registration and post-launch. The candidate could also support business development due diligence activities.

Candidates should be prepared to come to the office 2-3x/week.

Responsibilities

• Provide Global Strategic Regulatory overview for respective products and portfolio.

• Be the Global regulatory point of contact to the alliance partners and/or health agencies (as determined by specific deal agreement).

• Work with alliance management and relevant functions in integration of new assets into Organon; lead regulatory sub team in strategic and operational aspect of integration work.

• Guide relevant internal R&D stakeholders and teams, as well as working closely with alliance partners and commercial teams, in creating and implementing global regulatory strategy for registration, maintenance and market expansion of biosimilar products within the portfolio. Main regions of focus include US, EU, UK, Canada, Japan and Latin America.

• Review and approve regulatory submissions and background packages to ensure clarity and comprehensive presentation of issues.

• Review and approve communication materials to be used external to Organon such as press releases for accuracy and consistency of message.

• Represent Organon as needed at external initiatives, notably with regulatory authorities and/or trade association(s).

• Participate in projects and initiatives outside of current responsibilities as needed to drive the organization forward to success. 

• Contribute to determining solutions outside of current responsibilities as needed and manage day-to-day operational issues outside of current responsibilities, as needed.

• Work seamlessly with other R&D departments as well as commercial organization and manufacturing organizations.

• 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

• B.S., M.S., M.D. PharmD or PhD in biological science, chemistry or related discipline preferred.

• Regulatory experience required, with experience in biosimilars development.

• M.D., PharmD or PhD with five to seven years relevant drug development experience required, preferably with three to five years in Regulatory.

• M.S. or B.S. with seven to 12 years relevant drug development experience, a majority of which was in Regulatory. 

• Demonstrated scientific knowledge, writing ability, effective communication and thorough familiarity with worldwide regulatory agencies.

• Experienced in negotiations with health authorities.

• Outstanding interpersonal, communication and negotiation skills.

• Demonstrated leadership attributes; experienced at building and leading high performing teams; exemplifies corporate and ethical integrity; drives success consistent with company values and priorities.

• Deep competency in developing optimal regulatory strategy globally and understanding of regulatory requirements throughout the development spectrum (preclinical to post-marketing).

• Ability to solve problems through investigation and solution identification.

• High degree of professionalism and sound judgment.

• Driver of change and innovation. 

• Demonstrate sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations.

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