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. More specifically, this position will oversee staff who will manage the business development stages of strategy, evaluation, due diligence, contracting, implementation support and maintenance of regulatory activities relating to our Company business partner deals.  The scope of transactions to be supported include but are not limited to divestitures, mergers/acquisitions, in-licensing, and collaborations.

Responsibilities:

• The Director will have people management responsibilities that require oversight of team members in supporting the range of Business Development opportunities.  Additionally, the incumbent will assume the responsibilities for employee development and management consistent with Company leadership principles.

• Work with the 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 all 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 the partner relationship evolves over time.

• Have oversight across multiple projects with potentially complex integration points and fast paced timelines.  This will require helping the staff assess problem situations to identify causes, gather and process relevant information, generate possible solutions, and make recommendations and/or resolve the problem. 

Education requirement:

• 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. 

Required Skills:

Adaptability, Change Management, Detail-Oriented, Regulatory Affairs Management, Regulatory Compliance, Regulatory Compliance Audits, Regulatory Experience, Regulatory Strategy Development, Regulatory Submissions, Strategic Planning, Strategic Thinking

Preferred Skills:

Business Development

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.