Director Regulatory Strategy
Our client needs a Director, Regulatory Strategy who sees the world differently. We’re looking for a professional with at least seven (7) years of experience who doesn’t see obstacles but opportunity when it comes to the drug development industry. The Director, Regulatory Strategy position is a permanent, full-time salaried role and is located in Princeton, New Jersey. We’re looking for problem solvers, innovators and those inspired by the work we do in making a difference today and with future generations.
- Acts as liaison with the FDA for assigned investigational products, interacting with FDA personnel up to and including the Division Director level
- Determines regulatory requirements for clinical and pre-clinical submissions to FDA for assigned investigational products
- Assures that Regulatory Affairs is adequately represented on project teams for assigned products
- Oversees and evaluates performance of assigned Managers (permanent and contractor) of Regulatory Affairs
- Researches regulatory information related to assigned projects, including reviewing Web sites and print material, and interfacing with other staff or external consultants
- Interacts with other Directors/Senior Directors-Regulatory Affairs, CMC-Regulatory, Non-clinical Safety Evaluation, Clinical Management and Development, Program Management and Regulatory Submissions
- Develops strategies, drafts responses, or reviews responses and documents intended for submission to FDA
- Provides guidance to Project Teams on steps necessary to comply with regulatory legislation, regulations, and guidance documents
- Reviews documents and reports generated by RA Managers or other project team members to assess the likelihood that the content will meet pre-specified objectives
- Reviews and updates RA processes to ensure the efficient and timely flow of information
- 7-10 years of relevant drug development or preferably regulatory experience in the pharmaceutical or health-related industry
- Helpful to have 3-5 years of supervisory or management (direct or indirect) experience and experience negotiating internal and external drug development and drug product issues
- Solid understanding of the FDA organization and ICH guidelines
- Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
- Bachelor’s Degree required
- RAC certification is a plus
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
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.