Director, Regulatory Affairs - Framingham, MA or REMOTE (Northeast / East Coast)
The Director, Regulatory Affairs will work with Regulatory teams in the US and France in providing strategic direction in the implementation of strategies, policies, procedures, and optimal infrastructure to ensure systems are aligned with company submissions, corporate and applicable external regulatory authorities. This person/position will work closely with several client groups providing guidance and expertise relating to product registration in the US. This person/position may be asked to represent or participate on behalf of the client for Regulatory Agency interactions (correspondence, conference calls, in-person agency meetings, etc.).
- Serve as a member of the Regulatory team and provide leadership to a team of compliance, operational, technical, professional, and administrative staff that may or may not be direct reports. Provides guidance in interpreting government regulations and guidelines as they apply to products and practices.
- Work with Quality to ensure Quality System procedures and practices meet regulatory standards.
- Ensure products meet corporate and government standards and regulations.
- Assist in establishing and managing the compiling and reporting of department performance indicators.
- Make improvements and adjustments as required. Assists in coordinating regulatory inspections and preparation.
- Provide regulatory related input and review for internal programs across the client as requested.
- Interacts directly with the clients regulatory departments by both physical presence for such things as internal meetings, Mock Audits, input on submission development, submission reviews, and active participation in agency interactions and communications as appropriate.
- BS, MS, or equivalent industry experience (8+ years) with clear and practical Regulatory background with direct agency experience.
- Experience with CMC and clinical matters.
- Broad knowledge of all business disciplines to ensure ability to ‘partner’ with all functional departments of the organization.
- Demonstration of strategic planning, meeting objectives, technical and resource issue resolution.
- Strong leadership capabilities a must.
- Computer proficiency and familiarity with MS software applications.
- Excellent written, verbal and presentation skills.
- Ability to work and communicate with all levels within the organization and internationally.
- Must practice constructive engagement and have the confidence to challenge and be challenged to get the best strategies and solutions.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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