Executive - Regulatory Affairs & Pharmacovigilance

Why This Role Matters
Regulatory Affairs and Pharmacovigilance (PV) professionals ensure that pharmaceutical products are safe, effective, and compliant with evolving regulatory standards. This dual-function role is particularly valuable as it combines drug safety monitoring with regulatory submissions and lifecycle management. By managing safety reporting and regulatory compliance, professionals in this role directly contribute to patient safety, successful product approvals, and sustained market access.

Job Description
Ferring Pharmaceuticals is hiring an Executive – Regulatory Affairs & Pharmacovigilance in Mumbai, India. This role offers a unique opportunity to work across both regulatory and drug safety functions within a globally recognized specialty biopharmaceutical company. The selected candidate will be responsible for managing pharmacovigilance activities, supporting regulatory submissions, and coordinating with global and regional teams. This position is ideal for professionals with 1+ year of experience who are looking to build a long-term career in Regulatory Affairs and PV.

Key Features of the Role: Responsibilities

Pharmacovigilance (PV)
• Report safety information from India and South Asia to global safety teams.
• Follow up with reporters to collect additional safety data.
• Monitor and manage the safety mailbox.
• Perform monthly reconciliation and PV compliance checks.
• Prepare and submit Periodic Safety Update Reports (PSURs) to Indian regulatory authorities.

Regulatory Affairs
• Prepare and submit regulatory dossiers for new product registrations.
• Handle clinical trial applications, variations, and renewals.
• Coordinate with global regulatory teams for submissions and query responses.
• Support preparation for regulatory authority and expert committee meetings.
• Manage regulatory submissions for South Asia markets.
• Prepare and update product labeling and promotional materials.
• Maintain regulatory and pricing databases, including NPPA updates.
• Support lifecycle management and milestone tracking.
• Update local SOPs and Safety Agreements with partners and distributors.

Eligibility Criteria

Educational Qualification
• Bachelor’s degree in:
– Pharmacy (B.Pharm)
– Life Sciences
– Microbiology
– Chemistry or related fields

Experience
• Minimum 1+ year of experience in:
– Regulatory Affairs (India)
– Pharmacovigilance
– Pharma or Biotech industry

Required Skills
• Strong understanding of Indian regulatory guidelines and submission processes
• Knowledge of pharmacovigilance systems and safety reporting
• Experience in dossier preparation and lifecycle management
• Familiarity with PSUR submissions and compliance requirements
• Good communication and coordination skills
• Attention to detail and ability to manage multiple tasks

Preferred Skills
• Exposure to global regulatory environments
• Experience with South Asia regulatory submissions
• Knowledge of NPPA pricing regulations
• Familiarity with safety databases and regulatory tools

Salary Insights
• Competitive salary as per industry standards (early-career RA & PV role)

Benefits & Perks
• Global exposure to regulatory affairs and pharmacovigilance systems
• Opportunities to work across multiple therapeutic areas
• Strong career growth in RA & PV domains
• Inclusive, people-first work culture
• Comprehensive family-building benefits including fertility, adoption, and parental support
• Minimum 26 weeks paid parental leave
• Paid leave for fertility and adoption procedures

Company Overview
Ferring Pharmaceuticals is a global, research-driven biopharmaceutical company focused on developing innovative treatments in areas such as reproductive medicine, gastroenterology, and urology. With a strong global presence, Ferring is known for its commitment to patient-centered care, scientific innovation, and employee well-being. The company provides a collaborative environment where professionals can gain international exposure and contribute to impactful healthcare solutions.

FAQs

• Is this role suitable for freshers?
No, at least 1 year of relevant experience in Regulatory Affairs or PV is required.

• What is the main focus of this role?
A combination of pharmacovigilance activities and regulatory submissions.

• Does this role involve global exposure?
Yes, it includes coordination with global regulatory and safety teams.

Application Tips
• Highlight your experience in regulatory submissions and PV activities
• Mention knowledge of PSUR, NPPA, and Indian regulatory guidelines
• Include experience with safety reporting and compliance checks
• Emphasize coordination with cross-functional or global teams