About the Opportunity
We are partnered with a company that is seeking an experienced (Sr.) Director of Regulatory Affairs to lead the development and execution of global regulatory strategies supporting the clinical development and commercialization of innovative therapies. This individual will play a key role in regulatory planning, submission strategy, and cross-functional collaboration to ensure successful interactions with global health authorities.
The annual base salary range is $175,000 to $230,000. Actual compensation offered to the successful candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level, among other things. Details about eligibility for bonus compensation (if applicable) will be finalized at the time of offer.
Job Responsibilities
- Develop and execute global regulatory strategies to support product development, clinical trials, and marketing approvals
- Provide regulatory guidance to cross-functional teams and ensure alignment with overall development and business objectives
- Lead the planning, preparation, authoring, and review of regulatory submissions to global health authorities, including the FDA, EMA, and other international agencies
- Support regulatory submissions across the product lifecycle, including INDs, CTAs, NDAs, BLAs, and MAAs
- Ensure regulatory documentation is accurate, complete, compliant with global regulatory requirements, and delivered within established timelines
- Monitor regulatory deliverables, identify potential risks, and proactively implement mitigation strategies to support submission timelines
- Partner with cross-functional teams, external vendors, and regulatory operations to support submission planning, publishing, and document management activities
- Contribute to the continuous improvement of regulatory processes, document standards, submission workflows, and regulatory systems
Job Requirements
- Bachelor’s Degree required
- Master’s Degree in life sciences discipline preferred
- 7+ years experience in drug development and regulatory affairs
- Must have experience with regulatory submission documents
