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Inventia Healthcare, a leading player in the manufacturing and development of oral solid dosage systems, is seeking a highly experienced and strategic leader to join our team as Head – Regulatory Affairs at our R&D facility in Thane, Maharashtra, India.
This is a critical leadership role that will guide our regulatory strategy across all phases of product development and commercialization, ensuring global compliance and driving the timely approval of our innovative pharmaceutical products.
About Inventia Healthcare
Inventia Healthcare Limited, established in 1985, is committed to advancing patient care through innovations in drug delivery. We specialize in value-added oral solid dosage forms, including capsules, tablets, granules, and pellets, and operate a state-of-the-art, accredited manufacturing facility alongside our R&D center. Our regulatory success is built on a foundation of quality, with approvals from major international health authorities like the US FDA, UK MHRA, and Korea KFDA. Join a company where innovation and compliance meet to fill the gaps in global product portfolios.
Role Summary: Head – Regulatory Affairs
As the Head of Regulatory Affairs, you will be the final authority and strategic leader for all regulatory matters within Inventia. You will be responsible for creating, implementing, and managing the entire regulatory framework to support our R&D, manufacturing, and commercial objectives worldwide.
This executive role reports directly to the R&D Head and is pivotal in shaping the future growth of the company.
Key Responsibilities
- Global Regulatory Strategy: Design and execute comprehensive global regulatory strategies for new product development, lifecycle management, and registration across various international markets (including regulated and emerging markets).
- Agency Interaction: Act as the primary liaison and lead negotiations with national and international health authorities (e.g., US FDA, EMA, MHRA) to facilitate the timely submission, review, and approval of drug applications and variations.
- Compliance and Risk Management: Oversee all regulatory submissions, ensuring the highest standards of data integrity and compliance with evolving global regulations. Proactively identify regulatory risks and develop effective mitigation plans.
- Leadership and Mentorship: Lead, mentor, and develop the Regulatory Affairs team, fostering a culture of excellence, accuracy, and strategic regulatory thinking.
- Internal Collaboration: Provide expert strategic and technical advice to cross-functional teams, including R&D, Manufacturing, Quality Assurance, and Business Development, ensuring all activities are compliant with regulatory requirements.
Candidate Profile
We are looking for a visionary leader with a profound and proven track record in the pharmaceutical regulatory landscape.
- Experience: A minimum of 20+ years of progressive experience in Regulatory Affairs within the pharmaceutical industry. Experience with oral solid dosage forms and global filings (ANDA, Dossier, etc.) is highly preferred.
- Qualification: A Graduate or Postgraduate degree in Pharmacy or a closely related scientific field is required.
- Location: The role is based at our facility in Thane, India.
How to Apply
This is an exceptional opportunity for a seasoned regulatory professional to make a significant impact on a growing, globally focused pharmaceutical company.
Send your detailed resume, highlighting your relevant experience and qualifications, to: careers@inventia.com
