Walk in Drive API Regulatory Affairs Dept

2 weeks ago

Hyderabad Secunderabad, India MSN Group Full time ₹ 5,00,000 - ₹ 25,00,000 per year

Walk In Drive for API Regulatory Affairs Dept (RA) @ R&D Center

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

Interview Date: @Saturday

Interview Time :- 9AM TO 2PM

Venue Details :

MSN Laboratories Pvt. Ltd.,

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

Contact :

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 1-7 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

Qualification : M.sc

Work Location : MSN R&D Center, Pashamylaram.

Department : API Regulatory Affairs Dept - ( API RA )

Experience : 1 to 7 Years

Job Location :

MSN Laboratories Pvt.Ltd.,

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

Interested Candidates can share there CVs to

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