We are looking for a Manager of Regulatory Affairs, working in the Biotechnology/Medical Devices industry in Cambridge, Massachusetts, United States.
Works with Regulatory Affairs management to define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements.
Develops detailed regulatory project plans and lead or support regulatory activities relating to specific portfolio of products/projects.
Participates as an active team member of the Global Regulatory Teams for assigned programs and provide strategic regulatory advice to project teams as required.
Coordinates responses to regulatory authorities questions with strict deadlines.
The pay range we are offering is 65 to 100 per hour. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
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
Solid understanding of regulations and experience in interpretation of guidelines
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
Excellent written and verbal communication skills, including negotiation skills
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
Ability to think strategically and to proactively identify issues in various aspects of the drug development process
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
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.