Regulatory Affairs Leadership Role
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* About the Role
We are seeking an experienced Regulatory Affairs Manager to lead our regulatory strategy implementation and operations for product registration submissions, progress reports, supplements, amendments, and periodic experience reports.
* Key Responsibilities
* Main Objectives:
1. Lead and Oversee: Guide the strategy implementation and operations for product registration submissions, progress reports, supplements, amendments, and periodic experience reports.
Responsibilities Include:
* Collaborate with Regulatory Agencies: Expedite approvals by interacting directly with regulatory bodies, ensuring clear and concise communication.
* Serve as a Liaison: Act as the regulatory representative throughout the product lifecycle, working closely with marketing, research teams, and regulatory agencies.
* Drive Product Approvals: Ensure timely approval of new drugs, biologics, or medical devices, and maintain continued approval of marketed products.
* Advise Teams: Provide expert advice on manufacturing changes, line extensions, technical labeling, and regulatory compliance.
* Required Skills and Qualifications
* Manufacturing Expertise: Hands-on experience in manufacturing operations and managing manufacturing changes.
* Leadership Skills: Proven experience in people management and resolving nonconformance issues.
* Detail-Oriented Mindset: Strong attention to detail and excellent organizational skills.
* Communication Skills: Ability to communicate effectively at all levels, particularly with EU and US regulatory bodies.
* Qualifications and Experience
* Educational Background: A minimum Level 8 Degree in Engineering, Science, or a related discipline.
* Professional Experience: At least 5 years in a similar role with experience in EU regulatory bodies regarding applications and submissions, or equivalent international experience.
Benefits of this Role
* This is an exciting opportunity to work with a talented team and make a meaningful impact on the industry.
* The successful candidate will have the opportunity to develop their skills and expertise in regulatory affairs.
* The company offers a competitive salary and benefits package.