Senior Manager Regulatory Strategy
Are you a Senior Manager Regulatory Strategy professional with five years of experience? Our client has an amazing opportunity for a Senior Manager Regulatory Strategy located in Princeton, New Jersey. This role will provide regulatory expertise and support for pre-clinical and clinical areas for investigational and marketed products; develops and oversees the strategic implementations of electronic regulatory submissions processes and systems. Apply now to talk to one of our recruiters and learn more about this progressive career opportunity.
- 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
- 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 Senior Directors-Regulatory Affairs, CMC-Regulatory, Non-clinical Safety Evaluation, Clinical Management and Development, Program Management and Regulatory Submissions to ensure continuity for assigned investigational products
- Develops strategies, drafts responses, or reviews responses and documents intended for submission to FDA to assure compliance with regulatory standards
- 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 among the project team
- At least 5 years of relevant drug development or preferably regulatory experience in the pharmaceutical or health-related industry
- 2-3 years of supervisory or management (direct or indirect) experience and experience negotiating internal and external drug development and drug product issues is desirable
- Requires strong working knowledge of the drug development process, drug laws, regulations, and guidelines
- 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)
- Minimum of Bachelor’s Degree
- RAC certification is desired
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.