API Regulatory Affairs Dept (RA).

Job highlights

• M.Sc with 2-10 years regulatory affairs experience in pharmaceutical API sector
• Prepare and manage regulatory submissions, maintain documentation, ensure compliance, liaise with authorities, and support cross-functional teams

API Regulatory Affairs Dept (RA) @ R&D Center

Work/Interview Location :- MSN R&D Center, Pashamylaram, Isnapur, Telangana

MSN Laboratories Pvt. Ltd.,

MSN R&D center, Pashamylaram, Isnapur, Patancheru, Sangareddy

Regulatory Affairs Specialist to join our API Division. This role is critical to ensuring compliance with regulatory requirements for our active pharmaceutical ingredients (APIs). The ideal candidate should have 2-7 years of regulatory affairs experience in the pharmaceutical industry.

Key Responsibilities:

Regulatory Submissions: Prepare, submit, and manage regulatory filings for API products, including new drug applications, amendments, and variations, while ensuring compliance with relevant guidelines and regulations.

Documentation Management: Maintain, review, and update regulatory documentation, including drug master files (DMFs) and technical files, to support product registrations and renewals.

Compliance Assurance: Stay up-to-date with regulatory changes, assess the impact on products, and provide recommendations for maintaining compliance.

Communication: Interact with regulatory authorities, addressing inquiries, requests, and managing inspections and audits as required.

Cross-functional Collaboration: Work closely with internal teams, including R&D, quality assurance, and production, to provide regulatory guidance and support for API-related activities.

Quality Standards: Ensure that API products meet quality and safety standards in alignment with Good Manufacturing Practices (GMP) and other relevant quality regulations.

Regulatory Strategy: Contribute to the development of regulatory strategies for product development and lifecycle management.

Position : Executive / Sr Executive/Jr Manager / Asst Manager

Qualification : M.sc

Work Location : MSN R&D Center, Pashamylaram.

Department : API Regulatory Affairs Dept - ( API RA )

Experience : 2 to 10 Years

Job Location :

MSN Laboratories Pvt.Ltd.,

MSN R&D center, Pashamylaram, Isnapur, Patancheru,Sangareddy

Interested Candidates can share there CVs to

[email protected]