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B.Pharm/M.Pharm – Regulatory Affairs Officer | Sarigam
Join Senador Laboratories Pvt. Ltd, part of the global European company Insud Pharma, a leader in manufacturing and marketing female healthcare pharmaceutical products. With cutting-edge facilities in Ahmedabad and Sarigam, Senador Laboratories is committed to delivering high-quality, innovative healthcare solutions for women worldwide. We are currently seeking a Regulatory Affairs Officer (Male) to join our team at Sarigam (near Vapi).
Company Overview
Senador Laboratories Pvt. Ltd is a leading pharmaceutical company specializing in women’s healthcare. As part of Insud Pharma, a global European entity, the company emphasizes quality, compliance, and innovation in pharmaceutical manufacturing. The Sarigam and Ahmedabad facilities are equipped with state-of-the-art technology to ensure the highest standards in production, regulatory compliance, and product development.
Job Role & Responsibilities
As a Regulatory Affairs Officer, you will play a crucial role in ensuring compliance and smooth regulatory submissions. Key responsibilities include:
- Compile, review, and share technical data for regulatory submissions, including new projects, site transfer projects, and product re-qualifications
- Ensure timely availability of technical inputs for clearance of documents, including Product Recipe, Packaging Recipe, Artworks, and Specifications
- Review and approve technical documents such as BMR/BPR, stability protocols, transit trial protocols, and change controls
- Ensure compliance with regulatory audits and requirements
- Collaborate with cross-functional teams to maintain accurate documentation and regulatory standards
Eligibility / Qualifications
- Education: B.Pharm or M.Pharm
- Experience: Minimum 1 to 4 years in the pharmaceutical industry, preferably in regulatory affairs
- Key Skills:
- Strong understanding of regulatory submission processes
- Knowledge of documentation review, technical data handling, and regulatory audits
- Ability to ensure compliance across OSD formulations and projects
- Excellent analytical, documentation, and communication skills
Location & Work Details
- Job Location: Sarigam (near Vapi), Gujarat, India
- Work Environment: Dynamic pharmaceutical regulatory team
- Sector: Pharmaceutical / OSD formulation
Application Process
Interested candidates can share their CV and profile with Jigar Mahida at jigar.mahida@senadorlabs.com. Ensure your profile highlights relevant regulatory affairs experience, technical knowledge, and compliance skills.
Apply promptly to be part of a global pharmaceutical company and advance your career in regulatory affairs.
Why Join Senador Laboratories?
- Be part of a global European pharma company focused on women’s healthcare
- Hands-on exposure to regulatory submissions and compliance audits
- Develop expertise in document review, technical data management, and product re-qualifications
- Collaborate with cross-functional teams in a professional and growth-oriented environment
- Opportunities for career advancement in pharmaceutical regulatory affairs
FAQs
Q1. Who is eligible for this role?
B.Pharm or M.Pharm graduates with 1–4 years of experience in pharmaceutical regulatory affairs.
Q2. Where is the job location?
Sarigam, near Vapi, Gujarat, India.
Q3. What are the key responsibilities?
Regulatory submissions, document review, technical data compilation, approval of BMR/BPR/stability protocols, and audit compliance.
Q4. Is prior regulatory experience mandatory?
Yes, experience in regulatory affairs within the pharmaceutical industry is required.
Q5. How can I apply?
Send your CV to jigar.mahida@senadorlabs.com.
Job Summary Table
| Company | Senador Laboratories Pvt. Ltd |
|---|---|
| Vacancies | Regulatory Affairs Officer (Male) |
| Required Education | B.Pharm, M.Pharm |
| Experience | 1–4 years in pharmaceutical industry |
| Location | Sarigam (near Vapi), Gujarat |
