Work with the Global Regulatory Lead and Regulatory Affairs management to lead and define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements and lead EU HA interactions. Develop detailed regulatory project plans and support regulatory activities relating to specific portfolio of products/projects. Provide strategic regulatory advice to project teams. Coordinate responses to regulatory authorities' questions with strict adherence to deadlines. Facilitate as necessary the review of technical regulatory documentation and recommend changes to documentation or processes, including SOPs for regulatory compliance. Provide EU specific regulatory intelligence to internal stakeholders as appropriate. Bachelor's degree with extensive knowledge/experience in a Regulatory Affairs role working in the biotech or pharmaceutical industry. Excellent written and verbal communication skills, including negotiation and influencing skills. Solid understanding of regulations and experience in interpretation of guidelines. Ability to think strategically and to proactively identify issues and mitigation strategies in various aspects of the drug development process. Experience with regulatory filings, including electronic submissions, e.g., CTAs, post-marketing variations, 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. Clear alignment with Alnylam Core Values including: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, and Passion for Excellence.
