Director, Global Regulatory Affairs & Clinical Safety Business Development

Job Description

Under minimal guidance from the Senior Director, Business Development, the incumbent is responsible for representing Regulatory Affairs on business development transactions from deal initiation through potential signing. The position will oversee staff who manage the business development stages of strategy, evaluation, due diligence, contracting, implementation support and maintenance of regulatory activities relating to company business partner deals. The scope of transactions supported includes divestitures, mergers/acquisitions, in‑licensing and collaborations.

• People management responsibilities: oversight of team members supporting business development opportunities; employee development and management consistent with company leadership principles.
• Work with staff to manage the strategy, negotiation and provisions of regulatory components of agreements as they relate to product acquisitions, collaborations, distribution, comarketing, copromotion, tech transfer, joint ventures and divestitures.
• Collaborate with functional areas within Global Regulatory Affairs and Clinical Safety as well as Corporate Business Development, Clinical Research, Commercial, Manufacturing and other groups as deals require.
• Support the development of new business development agreements with a focus on regulatory aspects for complex deals; maintain existing agreements that require updating as partner relationships evolve.
• Oversee multiple projects with potentially complex integration points and fast‑paced timelines; help staff assess problem situations, generate solutions and make recommendations or resolve problems.

• Bachelor's degree. At least 7 years' experience in the pharma industry or adjacent field such as health authority.
• Advanced degree, preferably in regulatory or other science discipline, would be a plus.

Adaptability, change management, detail‑oriented, regulatory affairs management, regulatory compliance, regulatory compliance audits, regulatory experience, regulatory strategy development, regulatory submissions, strategic planning, strategic thinking.

Business development.

$ – $. Additional compensation may include annual bonus and long‑term incentive.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities.