Job Summary:
The Regulatory Affairs Manager prepares and submits drug product application to respective regulatory authorities and communicate with regulatory agencies for all pre and post approval requirements.
Duties/ Responsibilities:
- Develops strategies to ensure the company’s activities comply with government regulations.
- Serves as a liaison between regulatory bodies and operating divisions of the company.
- Prepares and submits Dossiers and reports to applicable regulatory agencies.
- Responds to requests for information from regulatory bodies.
- Coordinates with operations departments regarding production design and development to ensure compliance with regulations.
- Maintains current knowledge of regulations applicable to the company.
- Monitors regulatory affairs and the effect changes will have on company operations.
- Develops and maintains professional relationships in federal, state, and local regulatory agencies.
- Performs other related duties as assigned.
Required Skills/Abilities:
- Extensive knowledge of applicable government regulations.
- Ability to inform and educate managers and department heads on regulations and polices that require compliance.
- Excellent written and verbal communication skills.
- Excellent analytical and problem-solving skills.
- Excellent strategic planning skills.
- Proficient with applicable database and compliance software.
- Proficient with Microsoft Office
Education and Experience:
- Masters degree in pharmaceutical sciences
- One to three years of related experience required.