Manager/Sr. Manager Regulatory Affairs– Emerging Markets

1 day ago

Navi Mumbai Maharashtra India, Maharashtra Umedica Laboratories Private Limited Full time

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.UMEDICA was founded in 1983 and has business operations in more than 85 countries including EU, UK, USA, Canada, Australia, Middle East, Central & South American countries, Africa, Asia & CIS countries.We at UMEDICA strive to achieve more through a culture of innovation & continuous improvement.As part of our further expansion and growth plans, we are looking to hire Manager / Sr Manager Regulatory Affairs– Emerging Markets in Regulatory Affairs department.This position is based at our R&D center at Turbhe Navi Mumbai and will report to the Head Regulatory Affairs.The remuneration package will be commensurate with the incumbent’s professional experience and will be in line with market standards.Role & responsibilities:Regulatory Strategy & Planning: Develop and implement strategic plans for regulatory submissions and ongoing compliance. Submission Management: Oversee the preparation and submission of regulatory applications and amendments to relevant agencies. Agency/Customer Interaction: Serve as a primary point of contact with customer/regulatory authorities, representing the company. Lifecycle Management: Manage the regulatory lifecycle of approved products, including handling post-approval changes, supplements, and annual renewals. Documentation & Reporting: Critically review and approve all regulatory documents for accuracy, completeness, and adherence to regulatory standards. Audits & Inspections: Coordinate and support company activities during regulatory agency audits and inspections. Team Leadership & Collaboration: Guide and mentor junior staff, manage multiple projects simultaneously, and collaborate with internal cross-functional teams and external counsel. Required Skills & Qualifications:Education: Bachelor’s or master’s degree in pharmacy (B. Pharm, M. Pharm). Experience: 13-15 years of experience in regulatory affairs, with emerging market experience Technical Expertise: Deep understanding of CMC documentation (Chemistry, Manufacturing, and Controls) and the product development process. Communication: Excellent written and verbal communication skills for internal coordination and external agency interactions. Problem-Solving: A solution-oriented mindset with a capability for risk assessment and mitigation.

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