Director, Regulatory Affairs Business Development
AbbVie
Director leading regulatory scientific assessment and due diligence for business development activities at a pharmaceutical company. Responsible for evaluating acquisition and licensing opportunities, developing regulatory strategy, managing cross-functional teams, and communicating risk assessments to executive leadership.
Responsibilities
- Conduct regulatory scientific assessments for in-licensing, out-licensing, and acquisition opportunities
- Lead cross-functional teams evaluating new business opportunities and formulating regulatory recommendations
- Develop regulatory strategy and risk mitigation plans supporting development scenarios and financial modeling
- Negotiate regulatory activities and requirements within business transaction contracts and agreements
- Manage regulatory budget, internal resources, and external consultants supporting due diligence activities
Requirements
- Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related field
- 7+ years regulatory affairs experience, including drug development in US and Canada
- 5+ years in strategic leadership role with strong project management skills
- Experience in complex matrix environments influencing cross-functional teams
- Strong communication and negotiation skills with government regulatory agencies
- Knowledge of global regulatory environments (US, EU, Japan, China) and pharmaceutical guidelines
- Advanced degree or relevant certification preferred
Vacancy posted 2 days ago
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