Job Title: Head Regulatory Affairs
Department: Regulatory Affairs
Experience: 20 + years

Location: Thane
Reports To: R&D; Head

Position Summary:

We are seeking an accomplished Regulatory Affairs leader with over 20 years of experience to head our global regulatory function. The ideal candidate will possess deep domain expertise in regulatory requirements across international markets, especially in the generics pharmaceutical space, and have a proven ability to lead cross-functional regulatory strategies, ensure compliance, and influence business outcomes.

Key Responsibilities:

1. Regulatory Strategy
- Develops and implements robust regulatory strategies aligned with business objectives and market requirements.
- Plans and oversee timely regulatory filings and approvals for products across global markets.
- Modifies and adapt strategies proactively to accommodate evolving regulatory frameworks.
- Participates in apex cross-functional committees for the development and launch of current products in the generic portfolio.




- Recommends alternate regulatory pathways and mitigates risk to ensure regulatory goals are met within defined timelines.

2. Regulatory Advisory
- Tracks and interprets changes in global regulatory requirements and communicates implications across functions.
- Acts as a strategic advisor to IPMG, R&D;, QA, Manufacturing, Marketing, Materials, and Projects teams.
- Ensures complete and accurate documentation for filings and coordinates closely for timely submissions.
- Advises internal stakeholders on compliance related to quality, documentation, and change control.
- Liaises with international regulatory agencies and consultants to manage submissions, queries, and compliance expectations.
- Supports key customers with regulatory guidance and technical documentation for their own filings.
- Reviews and finalizes all submission dossiers to ensure completeness and alignment with authority’s expectations.
- Manages lifecycle maintenance of approvals incl

📌 Head -- Regulatory Affairs (Mumbai)
🏢 Inventia Healthcare
📍 Mumbai