Senior Director, Regulatory Affairs Job in Raleigh, North Carolina US
Position Description
Senior Director, Regulatory Affairs
This role directs and oversees both Regulatory Operations and the Regulatory Consultant function within the company. The primary focus of this role is to provide senior leadership for Regulatory Affairs and for liaising and driving business development opportunities with clients about their regulatory needs.
GENERAL RESPONSIBILITIES:
Leads, directs and provides the oversight and performance management of Regulatory Affairs (RA) staff, including but not limited to:
* Participate in the hiring of Regulatory Staff members
* Participate in performance feedback management as necessary to correct performance issues, compliance findings, audit observations, etc.
* Prepare and conduct performance appraisals.
* Implement and track individual and group productivity measures.
* Develop and implements strategies, policies and tools for the global regulatory affairs functions in order to improve efficiencies and consistency.
* Serve as the primary driver responsible for business development strategies, and growth for the Regulatory Consultancy function in support of this being a stand alone profit center for the business.
* Evaluate training requirements for departmental roles/responsibilities and direct applicable resources for completion of required training sessions.
* Serve as an expert resource on the interpretation and application of global regulations, including consulting with and providing feedback to sponsors regarding their regulatory needs.
* Directs and manages drug safety reporting and risk management requirements for the organization. Directs the coordination of regulatory affairs timelines with other departments to facilitate project tracking activities and on-time delivery of milestones.
* Prepare various complex regulatory submissions as required (e.g., CTAs, INDs, ANDAs, NDAs, ANDSs, NDSs, etc.).
* Establish and track departmental performance metrics.
* Participate in feasibility evaluations of potential studies.
* Provide guidance for the company with respect to ICH and the following regulatory bodies: HPFB, FDA, EMEA, MHRA, TGA, ANVISA.
* Develop annual budgets and manage financial activities for the regulatory affairs group by providing ongoing cost tracking and controls.
* Work with the Quality Systems group and site management in the development/revision and implementation of SOPs as required.
* Ensure compliance with appropriate SOP's, GCP and ICH guidelines.
SKILLS AND QUALIFICATIONS:
* Masters of Science Degree in a scientific, healthcare or pharmaceutical field, or equivalent experience. Having received industry certification in Regulatory Affairs is an asset.
* Minimum of 10 years' experience in regulatory affairs in the pharmaceutical, biotech, medical device or other FDA (or similar) regulated industries.
* Minimum of 7 years in a managerial or supervisory position.
* Expert knowledge of, and remaining current with, regulatory requirements pertaining to clinical research (HPFB, FDA, EMA, MHRA, as well as GCP, GLP, Regulated Bioanalysis, etc.), and having a solid understanding of the philosophises behind these regulations.
* Extensive experience in various regulatory submissions to the US-FDA and Health Canada, EMA and other regulatory agencies. Having experience in other international submissions is an asset.
* Proficient in clinical trial applications for drugs, natural health products, biologics and medical devices.
* Superior analytical, problem solving and decision making skills, with an aptitude to appropriately apply scientific, regulatory and administrative knowledge to accomplish department and company goals.
* Evaluate and implement industry best practice regulatory standards for both the Regulatory Operations and Regulatory Consultancy functions.
Strong leadership, interpersonal and management skills in the areas of mentoring, staff development, motivation and personnel retention.
* Proven conflict management skills with the ability to provide leadership to others in response to situations and to escalate more critical decisions when relevant.
* Foreign languages a plus.
Please send resume, references and salary requirements for immediate consideration.
