Job opening for one of the leading Pharmaceutical company in market.
Location - Bareilly, Uttar Pradesh.
Duties/ Responsibilities:
1) Develops strategies to ensure the company's production activities comply with government regulations.
2) Serves as a liaison between regulatory bodies and operating divisions of the company.
3) Prepares and submits applications and reports to applicable regulatory agencies.
4) Responds to requests for information from regulatory bodies.
5) Coordinates with operations departments regarding production design and development to ensure compliance with regulations.
6) Assists with the development of standards for the company's operating and production procedures.
7) Maintains current knowledge of regulations applicable to the company.
8) Monitors regulatory affairs and the effect changes will have on company operations.
9) Develops and maintains professional relationships in federal, state, and local regulatory agencies.
10) Performs other related duties as assigned.
Required Skills/Abilities:
1. Extensive knowledge of applicable government regulations.
2. Ability to inform and educate managers and department heads on regulations and policies that require compliance.
3. Excellent written and verbal communication skills.
4. Excellent analytical and problem-solving skills.
5. Excellent strategic planning skills.
6. Proficient with applicable database and compliance software.
7. Proficient with Microsoft Office Suite or similar software.
8. Industry experience and knowledge of regulatory affairs
9. Expertise in medical law
10. Good English skills
11. Team spirit and resilience
12. Strong management and communication skills
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