Kapiva
Website:
kapiva.in
Job details:
Associate – Medical Affairs & Regulatory Affairs
Department: Medical Affairs & Regulatory Affairs
Experience: 0–2 years
Qualification: B.Pharm / M.Pharm / BAMS / Life Sciences or related discipline
Industry: Pharmaceutical / Ayurveda / Nutraceutical / Healthcare
Role Overview
We are looking for a curious, detail oriented and execution focused Associate to join the Medical Affairs & Regulatory Affairs team. The role will involve scientific literature research, regulatory documentation, product dossiers, FSSAI and AYUSH regulatory activities, and cross-functional coordination.
The ideal candidate should preferably have a Lifescience background, with a strong inclination to learn Ayurveda, nutraceutical / FSSAI and healthcare regulations and the ability to convert knowledge into timely execution.
Key Responsibilities
1. Medical & Scientific Affairs
- Conduct systematic and targeted literature searches across scientific databases and credible sources.
- Review scientific papers and prepare concise literature summaries.
- Support scientific substantiation of product ingredients, formulations and claims.
- Prepare literature reviews, evidence summaries, reference documents and scientific briefs.
- Support Medical Affairs in developing product dossiers, investigator brochures, scientific presentations and training materials.
- Track new scientific publications relevant to products and ingredients.
2. Regulatory Affairs – FSSAI
- Support preparation, compilation and maintenance of FSSAI regulatory documentation.
- Assist in reviewing product formulations, ingredients, claims, labels and supporting documentation from a regulatory perspective.
- Maintain regulatory records and supporting evidence.
- Coordinate with internal teams for documentation required for regulatory submissions and queries.
- Track changes in applicable FSSAI regulations and guidelines.
3. Regulatory Affairs – AYUSH
- Support AYUSH product licensing and regulatory documentation.
- Assist in preparation and maintenance of AYUSH product dossiers.
- Coordinate documentation related to formulations, ingredients, specifications, manufacturing and product claims.
- Support responses to regulatory queries and observations.
- Maintain an updated repository of licenses, approvals, submissions and regulatory correspondence.
4. Dossier & Documentation Management
- Prepare, compile and review product dossiers and regulatory files.
- Ensure documents are accurate, complete, traceable and appropriately referenced.
- Maintain regulatory trackers and documentation databases.
- Coordinate with R&D, Quality, Manufacturing, Medical, Marketing and Legal teams to obtain required information.
- Support preparation of documents for audits, inspections and regulatory reviews.
5. Regulatory Intelligence
- Monitor developments in AYUSH, FSSAI and other applicable healthcare regulations.
- Identify regulatory changes that may impact products, claims, labels or business activities.
- Maintain regulatory intelligence trackers and communicate relevant updates to stakeholders.
Candidate Profile
Essential:
- Strong interest in Medical Affairs and Regulatory Affairs.
- Good scientific literature search and interpretation skills.
- Strong attention to detail and documentation skills.
- Good written and verbal communication.
- Ability to work with multiple teams and manage timelines.
- Strong willingness to learn and take ownership of assignments.
Preferred:
- Pharma background – B.Pharm / M.Pharm / BAMS / BAMS MD
- Exposure to FSSAI, AYUSH, pharmaceutical, nutraceutical or herbal products.
- Experience in literature search, regulatory documentation or dossier preparation.
- Basic understanding of scientific publications and evidence-based claims.
- Exposure to regulatory databases and scientific literature platforms.
Key Competencies
- Learnability & curiosity
- Execution orientation
- Scientific thinking
- Regulatory awareness
- Documentation discipline
- Attention to detail
- Analytical ability
- Cross-functional collaboration
- Ownership and accountability
What We Are Looking For
We are particularly looking for someone who may not know everything on Day 1, but has the ability and attitude to learn quickly and execute effectively.
The role offers an opportunity to develop expertise across Medical Affairs, Regulatory Affairs, Ayurveda, FSSAI, AYUSH, scientific evidence generation and product lifecycle management.
Click on Apply to know more.
