Head -- Regulatory Affairs

Job Title: Head Regulatory Affairs
Department: Regulatory Affairs
Experience: 25 years

Location: Thane
Reports To: R&D Head

Position Summary:

We are seeking an accomplished Regulatory Affairs leader with over 22- 25 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

• 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 authoritys expectations.
• Manages lifecycle maintenance of approvals including annual updates, post-approval changes, and post-marketing commitments.

3. Regulatory Audits & Compliance

• Ensures audit readiness by conducting internal audits and ensuring adherence to regulatory commitments.
• Leads and coordinates responses to external regulatory audits across departments.
• Builds a strong compliance culture across teams and ensures alignment with company policies and ethical standards.

4. People Leadership

• Sets annual goals for the regulatory team and monitors progress against deliverables.
• Coaches, mentors, and develops team members through regular feedback and support.
• Identifies skill gaps and drives training interventions to build a high-performing, future-ready team.
• Champions cross-functional collaboration and a values-driven regulatory mindset.

Qualifications & Experience:

• Graduate/Postgraduate in Pharmacy or a related field.
• Minimum of 22-25 years of progressive experience in Regulatory Affairs, with strong exposure to regulated markets (e.g., US, EU, ROW). Exposure to Latam market is added advantage.
• Deep understanding of generic product regulations, dossier requirements (ANDA, MA, CTD/eCTD), and post-approval changes.
• Demonstrated experience interfacing with agencies like USFDA, EMEA, ANVISA, HRA, TGA, and others.
• Proven leadership experience in managing large teams and cross-functional collaboration.
• Strong strategic thinking, analytical, and decision-making skills.
• Excellent communication, documentation, and interpersonal abilities.