API Regulatory Affairs Dept (RA).

MSN Group; Telangana; On-site; INR 600,000 - 1,200,000; Full time

Job summary

MSN Laboratories Pvt. Ltd. is seeking a Regulatory Affairs Specialist for the API division. The role focuses on regulatory submissions, documentation management, and ensuring GMP-compliant API products. You will interact with authorities and coordinate with R&D, QA, and production teams.

Experience ranges from 2 to 10 years in pharma regulatory affairs, with MSc as a qualification. Location is MSN R&D Center, Pashamylaram, Telangana (India).

Qualifications

• Regulatory submissions and filings for API products.
• Maintaining regulatory documentation like DMFs and technical files.
• Keeping abreast of regulatory changes and advising on compliance.

Responsibilities

• Regulatory Submissions: Prepare, submit, and manage filings for API products.
• Documentation Management: Maintain DMFs and technical files for registrations.
• Compliance Assurance: Monitor regulatory changes and advise on impact.
• Communication: Interface with authorities and manage inspections/audits.
• Cross-functional Collaboration: Support API activities with R&D, QA, and production.
• Quality Standards: Ensure GMP alignment for API products.

Skills

Regulatory affairs

Documentation

Cross-functional collaboration

Education

M.sc

Job description

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