Looking for a Regulatory Affairs job in Gujarat? B&S Group is hiring a Regulatory Affairs Associate for its Vadodara office. This is an excellent opportunity for pharmacy and life sciences professionals with expertise in EU and UK regulatory submissions, Module 1 compilation, SmPC preparation, patient leaflets, and clinical/non-clinical documentation.
Candidates with experience in regulatory affairs, dossier preparation, deficiency responses, and marketing authorization submissions can explore this full-time onsite opportunity in Vadodara, Gujarat.
About B&S Group
B&S Group is engaged in pharmaceutical and healthcare solutions with a focus on regulatory compliance, product development, and international market submissions. The company supports global pharmaceutical registration activities across regulated markets including Europe and the UK.
Job Details
| Job Role | Regulatory Affairs Associate |
|---|---|
| Company | B&S Group |
| Job Location | Vadodara |
| Job Type | Full-Time |
| Workplace Type | On-site |
| Department | Regulatory Affairs |
| Experience | Relevant experience in EU/UK regulatory submissions preferred |
Key Responsibilities
The selected candidate will be responsible for:
- Compilation of Module 1 for EU and UK regulatory submissions
- Preparation of SmPC, Patient Leaflet (PL), and labeling documents as per EU QRD guidelines
- Preparation and review of clinical and non-clinical overviews including Modules 2.4 and 2.5
- Preparation of administrative and product information documents for obtaining Marketing Authorisations
- Drafting and reviewing deficiency responses for regulatory submissions
- Preparing clinical and non-clinical national phase submission documents
- Supporting regulatory submissions with scientific literature and BE study documentation
- Assisting in regulatory strategy development for clinical and non-clinical programs
Required Qualifications
Candidates with the following qualifications are encouraged to apply:
- B.Pharm
- M.Pharm
- Pharm.D
- Life Sciences or related disciplines
Preferred skills include:
- Knowledge of EU and UK regulatory requirements
- Experience with CTD/eCTD submissions
- Understanding of QRD templates and labeling requirements
- Strong scientific writing and document review skills
- Familiarity with clinical and non-clinical regulatory documentation
Why Apply for This Regulatory Affairs Job?
This Regulatory Affairs Associate role offers exposure to:
- International regulatory submissions
- EU and UK pharmaceutical markets
- Marketing authorization processes
- Scientific and regulatory documentation
- Cross-functional pharmaceutical development programs
Professionals looking to build a long-term career in global regulatory affairs may find this role highly valuable.
Salary Expectations
Based on industry standards for Regulatory Affairs Associate roles in Gujarat, the expected salary may range between:
₹4.5 LPA – ₹8 LPA (depending on experience and expertise)
How to Apply
