BDR Pharmaceuticals Hiring Regulatory Affairs
- Company Overview
- Job Role & Responsibilities
- ROW Market
- US Market
- Eligibility / Qualifications
- Location & Salary
- Application Process
- Why Join BDR Pharmaceuticals?
- FAQs
- Summary Table
Regulatory Affairs Openings – BDR Pharmaceuticals, Gujarat
Apply for Regulatory Affairs Officer/Sr. Officer/Executive positions at BDR Pharmaceuticals, Gujarat. Experience required: US & ROW markets.
BDR Pharmaceuticals Internationals Pvt. Ltd., a leading pharmaceutical company with a strong global presence, is inviting skilled professionals to join its Regulatory Affairs Department. This is an excellent opportunity to work in a highly regulated environment and contribute to international pharmaceutical compliance and product registrations.
Company Overview
BDR Pharmaceuticals International Pvt. Ltd. is renowned for its commitment to quality, regulatory compliance, and global market expansion. The company specializes in pharmaceutical formulations and regulatory affairs, ensuring compliance with international standards across ROW and US markets. The Gujarat facility is recognized for its adherence to GMP, USFDA, EMA, and ANVISA guidelines, making it an ideal workplace for regulatory professionals aiming for career growth in the pharmaceutical sector.
With a certified Great Place to Work culture and a dedicated focus on innovation and global compliance, BDR Pharmaceuticals provides employees a collaborative and learning-driven work environment.
Job Role & Responsibilities
Department: Regulatory Affairs
Location: Halol, Gujarat
ROW Market
Positions: Officer / Sr. Officer
Responsibilities:
- Compile and review regulatory dossiers, ensuring accuracy and compliance.
- Resolve regulatory queries and support cross-functional coordination.
- Maintain detailed documentation and track regulatory submission deadlines.
- Communicate effectively with internal teams and external stakeholders.
US Market
Positions: Executive / Sr. Officer
Responsibilities:
- Prepare and review regulatory dossiers including ANDA, NDA, INDS, MAAs, DMFs, and variations.
- Support registrations for international markets including Brazil (ANVISA), Canada (HC), and Australia (TGA).
- Ensure compliance with USFDA, EMA, HC, TGA, and ANVISA regulations.
- Collaborate with R&D, QA, and manufacturing teams for regulatory submissions.
- Stay updated on regulatory changes in US, EU, and Brazil markets.
Key Skills:
- Hands-on experience in dossier compilation and regulatory submissions.
- Strong documentation and accuracy skills.
- Excellent communication and coordination skills.
- Knowledge of international regulatory guidelines and compliance.
Eligibility / Qualifications
- Educational Qualification: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or related fields.
- Experience:
- ROW Market: Proficient in dossier compilation with strong attention to detail.
- US Market: Experience with ANDA/NDA submissions and international regulatory compliance.
- Strong interpersonal and analytical skills.
Location & Salary
Work Location: Survey No. 51/1/2, 52/1/2, Vanseti Village, PO-Tajpura, TA-Halol, District: Baska, Gujarat
Salary: Competitive and commensurate with experience.
BDR Pharmaceuticals offers a dynamic, collaborative work environment with opportunities for growth, training, and global exposure.
Application Process
Interested candidates may share their updated resume at:
dhairya.modi@bdrpharma.com
Alternatively, candidates seeking other roles can visit BDR Careers Page for further opportunities.
Apply before 20 October 2025 to secure your consideration.
Required Documents:
- Updated Resume
- Academic Certificates
- Experience Certificates
Why Join BDR Pharmaceuticals?
- Work in a global regulatory environment with exposure to US, EU, and ROW markets.
- Collaborate with experienced regulatory and cross-functional teams.
- Gain hands-on experience in international dossier submissions and regulatory compliance.
- Competitive compensation and career growth opportunities.
- Certified as a Great Place to Work.
FAQs
1. What are the positions available?
Officer, Sr. Officer, and Executive in Regulatory Affairs for ROW and US markets.
2. Who can apply?
Candidates with relevant experience in regulatory affairs, dossier preparation, and international regulatory compliance.
3. Can freshers apply?
No, this opportunity is for experienced professionals only.
4. Where is the job location?
Halol, Gujarat – BDR Pharmaceuticals International Pvt. Ltd.
5. How to apply?
Send your CV to dhairya.modi@bdrpharma.com or visit the BDR Careers Page.
Summary Table
| Category | Details |
|---|---|
| Company | BDR Pharmaceuticals International Pvt. Ltd. |
| Vacancies | Officer / Sr. Officer / Executive – Regulatory Affairs |
| Required Education | B.Pharm, M.Pharm, Life Sciences, Biotechnology |
| Experience | Hands-on experience in dossier compilation & international regulatory submissions |
| Location | Halol, Gujarat |
| Application Email | dhairya.modi@bdrpharma.com |
| Last Date to Apply | 20 October 2025 |
Responses