BDR hiring Regulatory Affairs Executives & Managers for API DMF

MSc Regulatory Affairs API Jobs at BDR Pharma Vadodara

BDR Pharmaceuticals hiring Regulatory Affairs Executives & Managers for API DMF roles at Luna Plant, Vadodara.

BDR Pharmaceuticals International Private Limited has announced multiple openings in its Regulatory Affairs (API) department at the Luna manufacturing plant near Vadodara. This hiring drive is aimed at experienced regulatory professionals with strong exposure to global markets including ROW, US, EU, Canada, and Australia. The roles focus on Drug Master File (DMF) preparation, lifecycle management, and regulatory correspondence for API dossiers, offering an opportunity to work in a globally regulated pharmaceutical environment.

Company Overview

BDR Pharmaceuticals International Private Limited is a globally recognized pharmaceutical company specializing in Active Pharmaceutical Ingredients (APIs), oncology products, and complex generics. With a strong presence across regulated markets, BDR Pharma is known for its compliance-driven culture, scientific rigor, and robust regulatory strategies aligned with international standards.

The company’s Luna Plant in Vadodara supports API manufacturing and regulatory submissions for multiple global health authorities such as USFDA, EMA, TGA, Health Canada, and other international agencies. BDR Pharmaceuticals continues to expand its regulatory footprint through strong DMF portfolios and lifecycle management, making it a preferred employer for regulatory affairs professionals.

Job Role & Responsibilities

Regulatory Affairs – API (Global Markets)

Executive / Senior Executive – Regulatory Affairs

Experience: 4 to 8 Years

Key Responsibilities:

• Compiling and reviewing Drug Master Files (DMFs) as per country-specific regulatory requirements
• Preparing and submitting DMF amendments in accordance with global regulatory guidelines
• Handling regulatory submissions for ROW, US, EU, Canada, and Australia markets
• Preparing responses to regulatory authority queries within defined timelines
• Ensuring compliance with ICH guidelines and applicable regional regulations
• Coordinating with internal stakeholders for regulatory data compilation and review

Assistant Manager – Regulatory Affairs

Experience: 8 to 12 Years

Key Responsibilities:

• Managing end-to-end regulatory strategy for API DMFs across global markets
• Reviewing and approving DMF submissions and lifecycle amendments
• Handling regulatory communications with authorities such as USFDA, EMA, NMPA, TGA, Health Canada, and CADIFA
• Preparing, reviewing, and submitting responses to regulatory queries
• Providing regulatory guidance to cross-functional teams
• Ensuring adherence to global regulatory requirements and timelines

Eligibility / Qualifications

Required Education

• M.Sc (Chemistry)
• M.Pharm

Relevant Courses Include:
M.Sc Chemistry, M.Sc Pharmaceutical Chemistry, M.Pharm Pharmaceutics, M.Pharm Pharmaceutical Analysis, M.Pharm Regulatory Affairs

Experience Requirements

• Minimum 4–8 years for Executive / Senior Executive roles
• Minimum 8–12 years for Assistant Manager roles
• Hands-on experience in API regulatory affairs and DMF submissions
• Strong knowledge of ICH guidelines and global regulatory requirements

Location & Salary

Job Location:
BDR Pharmaceuticals International Private Limited
R.S. No. 578 & 579,
Near Effluent Channel Road,
Village: Luna, Taluka Padra,
District Vadodara – 391440

Salary Package:
Compensation will be competitive and aligned with industry benchmarks, based on experience and role level.

Application Process

Interested and eligible candidates can apply by sharing their updated resume via email or through the official career portal.

Email ID: mrunali.uttekar@bdrpharma.com

Career Page: https://bdrhrcareers.peoplestrong.com/job/joblist

Candidates are advised to mention the applied position in the email subject line.

Why Join BDR Pharmaceuticals

• Exposure to global regulatory submissions across multiple markets
• Strong DMF portfolio and API-focused regulatory work
• Opportunity to work with leading international regulatory authorities
• Structured growth path in regulatory affairs
• Compliance-driven and research-oriented work culture

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• BDR Pharmaceuticals Regulatory Affairs Jobs
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Frequently Asked Questions (FAQs)

Who can apply for BDR Regulatory Affairs API roles?

Candidates with relevant regulatory affairs experience in API DMF submissions can apply.

Which markets does this role support?

The roles support ROW, US, EU, Canada, Australia, and other global markets.

Is API regulatory experience mandatory?

Yes. Prior experience in API regulatory affairs and DMF handling is required.

Where is the job location?

The position is based at the Luna Plant near Vadodara, Gujarat.

How can I apply?

You can apply by emailing your resume or through the official BDR career portal.

Summary Table

Company	BDR Pharmaceuticals International Private Limited
Vacancies	Executive / Sr. Executive – Regulatory Affairs, Assistant Manager – Regulatory Affairs
Required Education	M.Sc, M.Pharm
Experience	4 to 12 Years