Boehringer Ingelheim is seeking a Director, US Product Group Regulatory Affairs to provide expert US regulatory leadership for assigned development projects and US marketed products, ensuring efficient and compliant drug development and product maintenance throughout the product lifecycle.
Requirements
- Expertise in multiple therapeutic areas and broad range of regulatory and drug development topics.
- Applies advanced critical thinking with the ability to self-direct workload, including prioritization and timely execution of deliverables in a fast-paced regulatory setting.
- Demonstrated understanding of the regulatory process and technical competence in core areas of drug development.
- Leads the interpretation of scientific and regulatory data across projects, translating insights into actionable strategies that align with local/global regulatory expectations and business objectives.
- Advanced proficiency in regulatory information management systems (RIMS), electronic document management systems (EDMS) and submission software (e.g., eCTD tools), along with advanced skills in Microsoft Office Suite.
- Leads all FDA interactions on assigned complex projects/products, including formal meetings, FDA review of registration packages, and labeling negotiations.
- Establishes and implements US regulatory strategy and goals for formal meetings with FDA that is aligned with project teams and RET.
Responsibilities
- Provide expert US regulatory leadership to the global and US cross-functional teams throughout the product lifecycle.
- Provide US strategic regulatory guidance to facilitate efficient and compliant drug development and product maintenance.
- Provide US regulatory input into the Global Regulatory strategy for assigned projects and represent US RA on US cross-functional teams.
- Act as primary company liaison with the US Food and Drug Administration.
- Develop comprehensive, well-thought through US regulatory strategies to navigate the intricate US regulatory landscape, ensuring compliance with relevant guidelines and regulations.
- Assess regulatory risks, options, and opportunities, anticipate potential challenges and propose innovative solutions to accelerate the development and approval process, leveraging the full breadth of US regulatory pathways.
- Collaborate closely with US stakeholders to align US regulatory strategies with the overall business objectives.
Other
- This role requires you to work on a hybrid schedule meaning 2-3 days per week at our Ridgefield, CT location
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required).
- Must be 18 years of age or older.
- Bachelor’s Degree in life sciences, pharmacy, or chemistry with extensive drug development experience/knowledge with a minimum of ten (10) years’ experience in Regulatory Affairs, FDA, or equivalent experience in the regulated pharmaceutical industry (biologics or small molecules) required.
