UMEDICA Looking to hire Head of Regulatory Affairs

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.

Looking to hire Head Of Regulatory Affairs - an aggressive / dynamic Regulatory Affairs Professional. Who would assume the Regulatory strategic, filing and post approval life cycle management and Quality / Technical and regulatory compliance responsibilities as per EU, UK, USA, and PIC/s requirements.

Essential skills and experience
The incumbent must have min. 20+ years’ experience in the pharmaceutical industry with a minimum of 15-20 years’ experience handling Regulatory compliance across the US, European and UK market. Specifically, the incumbent will be responsible for :
• Responsible for overall management and strategies of Regulatory affairs department at Umedica Labs.
• Responsible to support FR&D and QA / QC Teams for territory wise, essential regulatory and technical inputs and strategies to be followed for Regulatory filings
• Updating Umedica top management team for periodic updates – Monthly, Quarterly and annually and as per Management requirements.
• Responsible for planning to file original ANDA @USA, ANDS for our customers in Canada, EU MAs via DC and MR Procedures, UK PL applications via National and IRP route.
• Support BD teams for Dossier out licensing to South Africa, Malaysia, Singapore, Taiwan, Chile, Peru, GCC, Australia and other emerging markets.
• Support business development teams for product registration activities in SEA, ASEAN, North Africa, East and French West Africa countries for Legacy product portfolio and new registrations as per wish list by BD team/s.
• Develop and implement a comprehensive regulatory strategy that aligns with the company's overall business objectives.
• Coordination with Business development teams, customers and service providers for regulatory filings, in & out licensing activities of Umedica Product dossiers.
• Participate in management review meetings for launch and routine supply activities for approved / registered medicinal products. • Ensuring regulatory compliance and responsible for good regulatory practices to comply and support GMP aspects at Umedica, Vapi Manufacturing facility.
• Manage a team of regulatory professionals, providing coaching, mentoring, and ensuring their professional development.
• Preparing and getting necessary management approvals for infrastructure and annual budget and any CAPEX requirements for regulatory affairs department.
• Liason with accounts and finance team for necessary authority fees payments, and payments of service providers of Umedica for Regulatory affairs.
• Stay updated and vigilant on evolving regulatory requirements and industry trends, proactively identifying potential risks and opportunities.
• Manage the regulatory affairs budget and ensure efficient use of resources.
• Identify and implement strategies to mitigate regulatory risks and ensure product compliance.

Preferred Education requirements:
Masters in Pharmacy or Masters in science discipline.
Candidate having a post-graduation degree (i.e. QA/RA) will be good.
Additional Skills :
• Must have min. 15+ years core Regulatory filings and Team Management experience.
• Strong Leadership Qualities,
• Strong Verbal and Written Communication skills