- Work with Regulatory Affairs management to define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements. Regulatory documents may include the relevant forms, meeting requests, Briefing Documents for HA meetings, new Clinical Trial Applications (CTAs, INDs), Marketing Applications, Pediatric Plans, Orphan Designation and Expedited Pathway Applications, and any amendments thereto.
- Develop detailed regulatory project plans and lead or support regulatory activities relating to specific portfolio of products/projects.
- Participate as an active team member of the Global Regulatory Teams for assigned programs and provide strategic regulatory advice to project teams as required.
- Coordinate responses to regulatory authorities questions with strict deadlines.
- Serve as a liaison within internal departments at Alnylam, with CROs and with regulatory program managers at HAs.
- Maintain regulatory files in a format consistent with internal requirements.
- Facilitate as necessary the review of technical regulatory documentation and recommend changes to documentation or processes, including SOPs for regulatory compliance.
- Excellent written and verbal communication skills, including negotiation skills.
- Solid understanding of regulations and experience in interpretation of guidelines.
- Ability to think strategically and to proactively identify issues in various aspects of the drug development process.
- Experience with regulatory filings, including electronic submissions, e.g., INDs, CTAs, annual reports, safety reporting, etc.
- Excellent organizational and project management skills; demonstrated ability to prioritize multiple projects.
- Ability to work in a team environment, possessing interpersonal skills to work effectively with other departments at various levels and with CROs and external consultants.
- Technical system skills (e.g. word processing, spreadsheets, databases, online research) including submission-ready formatting.
- RAC certification and/or advanced science or healthcare degree are preferred
- Clear alignment with Alnylam Core Values including:
- Commitment to People,
- Innovation and Discovery,
- Sense of Urgency,
- Open Culture
- Passion for Excellence.
|Education:||Bachelor's degree with minimum of 3 years experience in a Regulatory Affairs role; minimum of 4 years experience working in the biotech or pharmaceutical industry or allied healthcare field.|