We are looking for a Associate Director of Regulatory Affairs, working in the Pharmaceuticals & Medical Products industry in Cambridge, Massachusetts, United States.
Works proactively in a cross-functional organization to partner with various other expertise areas and regional regulatory partners (as applicable) to plan and execute global regulatory filing strategies for company's programs across the portfolio.
Provides strategic regulatory leadership to project teams in early and late stage clinical development to advise on International filing requirements.
Leads the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product's life cycle. This will include orphan designation requests, meeting briefing documents, and International Marketing Authorization Applications.
The pay range we are offering is 100 to 130 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
Experience with leading International regulatory filings, including electronic submissions, e.g., INDs, CTAs, NDAs, MAAs, annual reports, safety reporting, etc.
Must be able and willing to work in a high-visibility, fast-paced environment
Must be flexible, detail-oriented, and possess good analytical and problem-solving skills
Works well on teams and also able to work effectively on own initiative and prepared to take ownership and responsibility for his/her actions
Superior verbal and written communication skills
Results focused and able to meet deadlines
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
Confident and has the professional competence to win respect and gain credibility at all levels within and outside the company; capable of representing the company externally
Adaptable and self-motivated, able to prioritize effectively with good problem-solving and planning abilities
Demonstrate clear alignment with Company's Core Values including, Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture and Passion for Excellence
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.