Regulatory Affairs Director

Inventia is into pharmaceutical development and manufacturing from last 40 yrs. We partner with pharma companies to research, develop, manufacture and distribute OSD. Our Manufacturing plant is in Ambernath which produces range of OSD including capsules, tablets, Granules and Pellets.

We are there in 45 countries and have 10 plus facility approvals including US EU.

Our corporate office is in Andheri and R&D is in Thane.

Recently, Platinum Equity acquired a controlling stake in Inventia Healthcare

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 new products in the generic portfolio.
• Recommends alternate regulatory pathways and mitigates risk to ensure regulatory goals are met within defined timelines.

2. Regulatory Advisory

3. Regulatory Audits & Compliance

4. People Leadership

Qualifications & Experience :