Director Regulatory Strategy
Our client has an opening for a highly qualified and skilled professional for the role of Director, Regulatory Strategy in Cambridge, Massachusetts. We are looking for a Director, Regulatory Strategy with a minimum of 5 years hands-on regulatory submission experience to be responsible for implementation of regulatory strategy and project team support for assigned products and projects.
- Assist in the planning, preparation and conduct of meetings with regulatory agencies as appropriate
- Initiate and prepare regulatory agency correspondence (telephone, written, meetings, etc.)
- Research and assess current and proposed regulatory, scientific and pertinent topics
- Review all documents to be submitted to regulatory agencies to ensure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance, and are presented in a way that facilitates agency review
- Guide project teams to implement regulatory strategies and provide regulatory support for product development and registration of assigned products
- Coordinate all regulatory activities required for submissions to regulatory agencies
- At least 5 years hands-on regulatory submission and project team experience
- Demonstrated knowledge of drug development process and the laws and regulations affecting the pharmaceutical industry
- Experience of successful NDA, BLA and/or MAA submission
- Bachelor’s Degree in the natural sciences or health related field
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
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