[Hiring] Director, Global Regulatory Strategy Lead @Boehringer Ingelheim

Role Description

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. The Director, Global Regulatory Strategy Lead will provide strategic regulatory guidance and leadership throughout the product lifecycle on assigned projects.

• Develop and own the Global Regulatory Strategy for assigned assets.
• Lead the Regulatory Excellence Team (RET) and represent Global Regulatory Affairs (GRA) on the Evidence Team.
• Craft comprehensive regulatory strategies to navigate the global regulatory landscape.
• Assess regulatory risks, options, and opportunities, and propose innovative solutions.
• Collaborate closely with stakeholders to align regulatory strategies with business objectives.
• Keep up to date on developments in the assigned therapeutic area.
• Engage in regulatory policy development and foster external stakeholder interactions.
• Lead and guide the RET, providing mentorship and support to team members.
• Facilitate effective communication and collaboration among team members.
• Serve as the main GRA representative on the Evidence Team.

Qualifications

• Bachelor’s degree in pharmacy, life sciences, or chemistry with seven (7) years’ experience in the regulated pharmaceutical industry (biologics or small molecule) required.
• Preferred: Master’s Degree or Doctoral Degree (e.g., PhD) in pharmacy, life sciences, or chemistry with five (5) years’ experience in the regulated pharmaceutical industry (biologics or small molecule).
• Further degrees/certifications: Specialized Pharmacist or Master of Drug Regulatory Affairs, RAC certification.

Requirements

• In-depth knowledge of latest regulatory science and global regulatory requirements.
• Demonstrated thorough understanding of the regulatory process and technical competence in drug development.
• Ability to analyze and interpret complex scientific data and regulatory guidelines.
• Strong strategic mindset with the ability to prioritize and deliver under tight timelines.
• Excellent verbal and written communication skills.
• Fluency with necessary computer software (MSWord, Excel, Project, etc.).

Benefits

• Medical, dental, and vision coverage.
• Retirement savings opportunities.
• Paid time off and paid holidays.
• Disability and life insurance benefits.
• Other company-sponsored programs.