Assures that changes to existing products are assessed against global and local Health Authority requirements and ensures timely registration of product Chemistry, Manufacturing, Controls (CMC) and labeling changes. Maintains registrations of existing products in compliance with applicable regulations.
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1. Develops regulatory strategies for lifecycle management projects and manufacturing improvements, and analyzes risk vs. benefit in regulatory strategies to ensure successful review by regulatory authorities.
2. Manages the preparation of registration packages and responses to deficiency letters. Negotiates submission data requirements and deliverable dates with regulatory authorities and internal technical teams. Author with team members, key pieces of regulatory submissions.
3. Acts as a point person for regulatory agency interactions (either written or oral) including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, and responses to agency letters pertaining to the assigned products/teams.
4. Evaluates manufacturing changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review.
5. Maintains awareness of global regulatory legislation and assesses its impact on business and product development programs.
For managers with people management responsibilities, provide managerial support and training to employees by supervising staff, establishing employee goals that align with other business partners, maintaining job descriptions, creating employee development plans, providing performance feedback and recruiting and retaining staff members.
Qualifications
A Bachelor's degree is required. Master's Degree preferred. 5-8 years experience in the pharmaceutical industry or relevant experience as needed for the position. A minimum of three years experience in regulatory affairs, research and development or quality assurance/compliance. Two years of direct people management experience preferred (for positions with people management responsibilities). Experience working directly with regulatory agencies. Sound knowledge of applicable portions of agency guidance and regulations. Excellent oral and written communication skills.
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