Job Description:
Regulatory Affairs Manager
Job Summary:
The Regulatory Affairs Manager will oversee the strategy implementation and operations for directing development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
Key Responsibilities:
1. Oversee strategy implementation and operations for directing development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
2. Interact with regulatory agencies to expedite approval of pending registration.
3. Serve as regulatory liaison throughout the product lifecycle.
4. Participate in product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
5. Ensure timely approval of new drugs, biologics, or medical devices and continued approval of marketed products.
6. Serve as regulatory representative to marketing, research teams, and regulatory agencies.
7. Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations.
Requirements:
1. Manufacturing operations and manufacturing change experience.
2. People management experience.
3. Experience resolving issues regarding nonconformance.
4. Strong attention to detail.
5. Solid communication skills and ability to communicate at all levels.
6. Experience with EU and US regulatory bodies.
7. Strong organizational skills.
Preferred Qualifications:
1. Ability to adapt to change.
2. Capacity to keep external communication clear and concise.
3. Experience reviewing manufacturing changes.
4. Optimization of regulatory acceptance changes.
5. Supporting manufacturing operations.
6. Dealing with Ad Hoc Issues.
7. Capability to work with tight deadlines.
Qualifications & Experience:
* Minimum Level 8 Degree in Engineering or Science or related discipline.
* Minimum of 5 years of experience in a similar position and experience with EU Regulatory bodies in regards to applications and submissions or equivalent international experience.