Executive to Manager - API Regulatory Affairs Dept (RA)

MSN Laboratories; Hyderabad; On-site; INR 500,000 - 1,000,000; Full time

Job summary

MSN Laboratories Pvt. Ltd. invites qualified candidates for API Regulatory Affairs roles at the R&D Center. Responsibilities include preparing regulatory submissions, maintaining DMFs and technical files, and ensuring GMP-aligned compliance across API projects.

The ideal candidate has 1–15 years in pharma regulatory affairs, with MSc in a related field, and will work from MSN R&D Center, Pashamylaram. The position offers progression to managerial levels.

Qualifications

• MSc in pharmaceutical regulatory affairs or related field.
• 1–15 years experience in regulatory affairs in pharma.
• Knowledge of API regulatory submissions and guidelines.

Responsibilities

• Prepare, submit, and manage regulatory filings for API products.
• Maintain and update regulatory documentation (DMFs, technical files).
• Monitor regulatory changes and assess impact on products for compliance.

Skills

Regulatory submissions

Documentation control

GMP knowledge

Regulatory surveillance

Education

MSc in Pharmaceutical Regulatory Affairs

Tools

DMF management

CTD drafting

Job description

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

Work Location MSN Laboratories Pvt. Ltd.,

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

Contact :- 9154811048

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 / Sr Executive /Asst Manager /Dy Manager/ Manager

Qualification : M.sc

Work Location : MSN R&D Center, Pashamylaram.

Department : API Regulatory Affairs Dept - ( API RA )

Experience : 1 to 15 Years

Job Location :

MSN Laboratories Pvt.Ltd.,

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