Manager/Sr. Manager Regulatory Affairs Emerging Markets

As a Manager/Sr Manager Regulatory Affairs Emerging Markets at UMEDICA, you will play a crucial role in the Regulatory Affairs department at our R&D center in Turbhe Navi Mumbai. Your primary responsibility will be to develop and implement strategic plans for regulatory submissions and ensure ongoing compliance. Your role will involve overseeing the preparation and submission of regulatory applications and amendments to relevant agencies. You will also serve as the primary point of contact with customers/regulatory authorities, representing the company. Key Responsibilities: - Develop and implement strategic plans for regulatory submissions and ongoing compliance. - Oversee the preparation and submission of regulatory applications and amendments. - Serve as the primary point of contact with customer/regulatory authorities. - Manage the regulatory lifecycle of approved products, including post-approval changes and annual renewals. - Critically review and approve all regulatory documents for accuracy and completeness. - Coordinate and support company activities during regulatory agency audits and inspections. - Guide and mentor junior staff, manage multiple projects, and collaborate with internal teams and external counsel. Qualifications Required: - Education: Bachelors or masters 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 and the product development process. - Communication: Excellent written and verbal communication skills for internal coordination and external agency interactions. - Problem-Solving: Solution-oriented mindset with a capability for risk assessment and mitigation. UMEDICA, a vertically integrated company founded in 1983, is engaged in manufacturing and exporting a wide range of finished formulations. With business operations in over 85 countries, UMEDICA fosters a culture of innovation and continuous improvement. The company's manufacturing facility in Vapi, Gujarat, is accredited by global regulatory agencies, including EU, PICs, Local FDA, and USFDA inspected. Join us as we expand and grow, offering a remuneration package commensurate with your professional experience and market standards.,