Regulatory Affairs & Pharmacovigilance Executive
- Company Overview
- Job Role & Responsibilities
- Pharmacovigilance Responsibilities
- Regulatory Affairs Responsibilities
- Pricing & Lifecycle Management
- Eligibility / Qualifications
- Educational Qualifications
- Experience Requirement
- Location & Salary
- Application Process
- FAQs – Executive Regulatory Affairs & Pharmacovigilance
- Who can apply for this role?
- Is this role suitable for freshers?
- What type of regulatory work is involved?
- Does the role include pharmacovigilance activities?
- Where is the job located?
- Is salary disclosed?
- Summary Table
B.Pharm / Life Sciences graduates required for Executive Regulatory Affairs & Pharmacovigilance role in Mumbai. Apply for 1+ year experience role.
Ferring India M&S is hiring an Executive – Regulatory Affairs & Pharmacovigilance for its Mumbai operations. This role sits at the core of regulatory compliance, drug safety, and lifecycle management. It is suited for professionals who understand Indian regulatory frameworks, pharmacovigilance operations, and cross-functional coordination with global teams. If you have hands-on experience in India Regulatory Affairs and PV functions and want to work in a global pharmaceutical environment, this role offers strong long-term career value.
Company Overview
Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical company with a strong global footprint. The organization is known for its focus on reproductive medicine, gastroenterology, and urology, with a clear commitment to patient safety, regulatory excellence, and scientific integrity.
Ferring India M&S operates in alignment with global regulatory and pharmacovigilance standards. The company maintains strict compliance with Indian regulatory authorities, global safety databases, and international reporting requirements. Working at Ferring means exposure to global regulatory systems, structured SOPs, and high accountability roles that directly impact patient safety and product lifecycle decisions.
Job Role & Responsibilities
As an Executive – Regulatory Affairs & Pharmacovigilance, you will manage both regulatory and drug safety activities for India and South Asia countries. The role requires precision, regulatory knowledge, and strong coordination skills.
Pharmacovigilance Responsibilities
- Reporting safety information from India and the India cluster, including South Asia countries, to the Global Safety team
- Reviewing and monitoring the safety mailbox for adverse event reports and related communications
- Following up with reporters to collect additional safety information and clarifications
- Performing monthly reconciliation activities and pharmacovigilance compliance checks
- Supporting preparation and submission of Periodic Safety Update Reports (PSURs) to regulatory authorities as per Indian regulations
- Maintaining and renewing safety agreements with partners, manufacturers, and distributors
Regulatory Affairs Responsibilities
- Gathering regulatory requirements and preparing dossiers for submission to Indian regulatory authorities
- Supporting regulatory submissions for new products, clinical trials, variations, renewals of registration certificates, and post-approval changes
- Preparing responses to regulatory authority queries and coordinating with global regulatory teams
- Contributing to preparation for regulatory authority meetings and expert committee discussions
- Preparing regulatory dossiers and managing follow-ups for South Asia countries
- Updating and maintaining product labeling materials in line with approved registrations
- Reviewing promotional materials to ensure compliance with approved product labels and regulatory guidelines
- Providing timely updates for regulatory databases and ensuring data accuracy
- Updating local SOPs in line with regulatory and pharmacovigilance requirements
Pricing & Lifecycle Management
- Coordinating price updates and ensuring timely entry of information into the NPPA pricing authority database
- Supporting lifecycle maintenance activities and communicating major regulatory milestones to the commercial team
Eligibility / Qualifications
Educational Qualifications
Candidates must hold a Bachelor’s degree in one of the following disciplines:
B.Pharmacy, Life Sciences, Microbiology, Chemistry, Biotechnology, Biochemistry, Pharmaceutical Sciences
Experience Requirement
- Minimum 1 year of experience in India Regulatory Affairs and Pharmacovigilance functions
- Experience must be from a pharmaceutical or biotechnology industry setting
- Hands-on exposure to regulatory submissions, safety reporting, and compliance activities is essential
Location & Salary
- Job Location: Mumbai, India
- Employment Type: Full-time
- Salary: As per company standards and candidate experience (not disclosed)
Application Process
Interested and eligible candidates can apply directly through the official company career portal using the link below:
Applications are open until January 30, 2026. Early applications are recommended due to high competition for regulatory affairs roles in Mumbai.
FAQs – Executive Regulatory Affairs & Pharmacovigilance
Who can apply for this role?
Candidates with a Bachelor’s degree in Pharmacy, Life Sciences, Microbiology, Chemistry, or related disciplines and at least 1 year of experience in Regulatory Affairs or Pharmacovigilance can apply.
Is this role suitable for freshers?
No. This position requires prior hands-on experience in India Regulatory Affairs and Pharmacovigilance functions.
What type of regulatory work is involved?
The role involves regulatory submissions, dossier preparation, authority interactions, labeling updates, promotional material review, and lifecycle maintenance.
Does the role include pharmacovigilance activities?
Yes. Safety reporting, PSUR submissions, safety agreement maintenance, reconciliation, and compliance checks are key responsibilities.
Where is the job located?
The position is based in Mumbai, India.
Is salary disclosed?
Salary details are not disclosed and will be offered based on experience and internal benchmarks.
Summary Table
| Company | Ferring India M&S |
|---|---|
| Vacancies | Executive – Regulatory Affairs & Pharmacovigilance |
| Required Education | B.Pharmacy, Life Sciences, Microbiology, Chemistry, Biotechnology, Biochemistry |
| Experience | Minimum 1+ years in India Regulatory Affairs and Pharmacovigilance |
To apply for this job please visit ferring.wd3.myworkdayjobs.com.
