Overview As Regulatory Affairs Manager, you will lead regulatory activities for assigned products and serve as the regulatory voice on cross-functional teams. You will develop and drive regulatory strategy for development and lifecycle management across North America, interfacing with FDA and Health Canada. Your work ensures compliant submissions, timely approvals, and ongoing regulatory support for leadership meetings. This role offers impact by shaping regulatory pathways and accelerating access to patient-centric medicines.
Responsibilities- Represent Regulatory Affairs on product and project teams, including external partners
- Assess regulatory implications for due diligence in business development
- Interface with FDA and Health Canada for assigned products
- Prepare and contribute to Health Authority meeting requests and briefing materials
- Attend Health Authority meetings as needed
- Drive regulatory strategies for drug product registration and lifecycle management
- Manage regulatory filings (IND, NDA, ANDA, NDS, DMF) across various dosage forms
- Respond to agency Requests for Information
- Oversee timelines and operational aspects of submissions
- Maintain regulatory submission archives and logs
- Provide guidance on post-approval changes and lifecycle activities
- Support SLT/ELT meetings with regulatory input
- Monitor evolving regional regulations and provide strategic compliance guidance
- Assist in budgets and manage relevant product/filing fees
- Participate in setting regulatory department goals and process improvements
Key requirements- Bachelor of Science or advanced health care degree (PharmD, PhD, MSc) or equivalent
- Minimum 10 years in pharmaceutical industry with at least 8 years in regulatory affairs
- Excellent organizational, interpersonal, verbal and written communication skills
- Strong grammar and editing skills; proficient in MS Office
- Proven track record of cross-functional collaboration, including external partners
- Ability to work independently in a fast-paced, deadline-driven environment
- Keen attention to detail
- Ability to adapt to changing environments with urgency while ensuring regulatory compliance
- Effective negotiation and influence of regulatory strategy with stakeholders
- cross-functional collaboration
- attention to detail
- effective communication
- Regulatory submissions (IND, NDA, ANDA, NDS, DMF)
- HA meeting preparation and participation
- FDA and Health Canada liaison
