BDR Pharmaceuticals is Hiring for Regulatory Affairs Jobs

Discover exciting pharma jobs in Regulatory Affairs at BDR Pharmaceuticals. Explore QA jobs, production roles, and pharmaceutical careers in India. Apply now for global impact!

About the Company

BDR Pharmaceuticals International Pvt. Ltd. is a dynamic leader in the pharmaceutical sector, specializing in innovative generics and APIs. With a robust global presence, the company prioritizes regulatory compliance, quality excellence, and sustainable growth.

Certified as a Great Place to Work from July 2024 to July 2025, BDR drives innovation while adhering to FDA, EMA, and international standards, fostering a credible reputation in pharmaceutical careers in India.

Job Details

• Company Name: BDR Pharmaceuticals International Pvt. Ltd.
• Experience: Varies by role, focusing on hands-on dossier compilation and regulatory expertise.
• Location: Survey No. 51/1/2, 52/1/2, Vanseti Village, PO-Tajpura, TA-Halol, District: Baska, Gujarat.

Job Description

BDR Pharmaceuticals is expanding its Regulatory Affairs team with key hires for ROW and US markets. These pharma jobs emphasize dossier management, compliance, and strategic submissions. Join to advance pharmaceutical careers in India with international scope.

Sr. Officer – Regulatory Affairs (ROW)

• Department: Regulatory Affairs
• Market: ROW
• Role: Sr. Officer
• Experience: Hands-on experience in dossier compilation and resolution of various queries

Officer – Regulatory Affairs (ROW)

• Department: Regulatory Affairs
• Market: ROW
• Role: Officer
• Experience: Proficient in dossier compilation with strong attention to detail

Executive – Regulatory Affairs (US)

• Department: Regulatory Affairs
• Market: US
• Role: Executive
• Experience: Prepared and reviewed regulatory dossiers (ANDA, NDA, variations) for US and EU markets; supported registrations for Brazil, Canada, and Australia

Sr. Officer – Regulatory Affairs (US)

• Department: Regulatory Affairs
• Market: US
• Role: Sr. Officer
• Experience: Collaborate with R&D, Plant QA, and manufacturing teams; prepare regulatory submissions (INDS, ANDAs, MAAs, DMFs)

Skills/Qualifications

• Proficient in dossier compilation and documentation management.
• Strong attention to detail for ensuring regulatory accuracy.
• Excellent communication skills for coordination and query resolution.
• Knowledge of FDA, EMA, HC, TGA, and ANVISA compliance guidelines.
• Ability to stay updated on US, EU, and Brazil regulatory changes.
• Experience in problem-solving and cross-team collaboration.

Key Responsibilities

• Compile and review regulatory dossiers for submissions.
• Ensure compliance with FDA, EMA, and regional guidelines.
• Support registrations in Brazil, Canada, and Australia.
• Communicate with authorities for approvals and queries.
• Collaborate with R&D, QA, and manufacturing teams.
• Manage documentation for ANDAs, INDs, and variations.

Benefits/Perks

• Great Place to Work certification for inclusive culture.
• Career growth in pharmaceutical careers in India.
• Competitive salary and performance incentives.
• Learning opportunities in global regulatory affairs.
• Work-life balance with collaborative environment.
• Exposure to innovative pharma jobs and projects.

How to Apply

Send your resume to dhairya.modi@bdrpharma.com, specifying the position in the subject line. For more pharma jobs, visit BDR Careers. Apply today—your next QA job or production role awaits!

Why You Should Join

BDR Pharmaceuticals offers a vibrant culture recognized by Great Place to Work, promoting teamwork and innovation. Enjoy long-term career stability in a compliance-driven environment that supports professional growth. Dive into cutting-edge pharma jobs, gain global exposure, and contribute to life-saving solutions in pharmaceutical careers in India.

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