Drug Regulatory Affairs Manager

As a Drug Regulatory Affairs Manager at Covalent, your role will involve leading the Global Regulatory Project Team, managing simple and complex regulatory submissions, and ensuring compliance with core labeling documents and internal standards. Your key responsibilities will include: - Leading the Global Regulatory Project Team, comprising internal members and external partners - Planning, preparing, and delivering regulatory maintenance, divestment, and withdrawal submissions - Maintaining core labeling documents and ensuring consistency with applicable standards - Providing expert regulatory advice and leading cross-functional delivery teams - Identifying and mitigating potential regulatory risks to operational plans - Supporting routine and non-routine interactions with health authorities and marketing companies - Monitoring and interpreting regulatory legislation and assessing its impact on product programs - Providing coaching, mentoring, and training to the Regulatory team - Maintaining compliance records and strong partnerships with internal and external stakeholders In terms of qualifications, you should have: - A University Degree in Science or related discipline - 6-12 years of relevant regulatory experience across various markets - Thorough knowledge of regulatory product maintenance processes - Leadership skills and experience working with cross-functional teams - Excellent English communication skills and scientific knowledge - Experience working with international stakeholders, particularly in Europe and/or the USA Your skills and capabilities should include: - Supplier and Partner management - Project management, problem-solving, and team working - Customer focus and understanding of Continuous Improvement principles If you are interested in this opportunity, please forward your profile to contact@covalenttrainings.com or reach out to us for guidance at +91-9848733309 or +91-9676828080.,