Regulatory Affairs Executive (US Market) Vacancy at BDR Pharmaceuticals

Regulatory Affairs Executive (US Market) Vacancy | M.Pharm | Vadodara

Apply for Regulatory Affairs Executive role at BDR Pharmaceuticals, Vadodara. Openings for M.Pharm graduates with 3–5 years of RA experience.

BDR Pharmaceuticals, a leader in specialty pharma and oncology care, is hiring Regulatory Affairs Associates / Senior Executives at its Vadodara, Gujarat facility. This opportunity is ideal for M.Pharm graduates with 3–5 years of regulatory affairs experience focused on CMC submissions for global markets including the US, EU, and Brazil. Join a company that is shaping access to affordable treatments and advancing healthcare worldwide.

Company Overview

BDR Pharmaceuticals International Pvt. Ltd. is a prominent name in the global pharmaceutical industry, known for its pioneering role in oncology and specialty generics. With a strong presence across international markets, BDR Pharma is committed to ensuring access to affordable medicines while maintaining stringent quality and compliance standards. The company’s regulatory affairs team plays a vital role in bringing critical therapies to patients by ensuring timely and accurate submissions to global health authorities.

Job Role & Responsibilities

As a Regulatory Affairs (RA) Executive, you will:

• Independently compile, review, and submit CMC dossiers in CTD/eCTD format to regulatory agencies such as US FDA, EMA, and ANVISA.
• Review CMC documentation for regulatory compliance and strategize appropriate filing categories.
• Conduct due diligence for new product registrations, particularly for complex injectable products.
• Provide regulatory strategy for multiple dosage forms including solids and injectables.
• Work cross-functionally with internal and external teams to ensure timely submissions.
• Evaluate change controls, assess regulatory impact, and implement appropriate filing strategies.
• Stay updated on global regulatory guidelines and ensure compliance with evolving standards.

Eligibility / Qualifications

• Education: M.Pharm (Pharmaceutical Analysis, Pharmaceutics, or Regulatory Affairs specialization).
• Experience: 3–5 years in CMC regulatory submissions for global markets (US, EU, Brazil).
• Technical Expertise:
  • Proficiency in ANDA and MAA submissions.
  • Hands-on experience with eCTD software and regulatory publishing tools.
  • Strong knowledge of FDA, EMA, and ANVISA regulatory guidelines.
• Skills Required:
  • Excellent communication and analytical skills.
  • Ability to strategize, prioritize, and manage multiple submissions.
  • Strong collaboration skills across multidisciplinary teams.

Location & Salary

• Location: Vadodara, Gujarat, India.
• Salary: Competitive, based on qualifications and experience. Additional employee benefits offered.

Application Process

Interested candidates can apply by sharing their resume at:
📩 dhairya.modi@bdrpharma.com
or apply via LinkedIn: Apply Here

Why Join BDR Pharmaceuticals?

• Be part of a fast-growing global pharma company with a strong oncology and specialty portfolio.
• Gain exposure to international regulatory submissions (US, EU, Brazil).
• Opportunities to work on complex CMC documentation and regulatory strategies.
• Collaborative and innovation-driven work environment.

FAQs

1. Who can apply for this RA Executive role?
M.Pharm graduates with 3–5 years of CMC and regulatory affairs experience for global markets.

2. What regulatory markets will I be working on?
You will focus on submissions to the US FDA, EMA (Europe), and ANVISA (Brazil).

3. Is eCTD experience mandatory?
Yes, hands-on experience with eCTD submission tools is required.

4. Where is this job located?
The role is based at BDR Pharma’s facility in Vadodara, Gujarat.

5. How do I apply?
Send your CV to dhairya.modi@bdrpharma.com or apply via LinkedIn: Apply Here

Call to Action

Advance your career in regulatory affairs with BDR Pharmaceuticals. Apply now for the Regulatory Affairs Executive role in Vadodara and contribute to bringing affordable, life-saving medicines to patients worldwide. Submit your application today before the position closes!

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