Drug Regulatory Affairs Manager

As a Drug Regulatory Affairs Manager at Covalent, you will be responsible for leading the Global Regulatory Project Team, comprising internal team members and external partners, to ensure the planning, preparation, and delivery of both simple and complex regulatory submissions and response documents on a global and regional scale. This includes maintaining core labeling documents, corporate approval of EU SmPC and US PI, and ensuring consistency with internal standards and SOPs. Your role will involve liaising with internal functions and external partners, leading cross-functional delivery teams, identifying regulatory risks, supporting routine and non-routine interactions with health authorities, and monitoring changing regulatory legislation. You may also serve as a delegate for the Global Regulatory Lead and provide coaching, mentoring, and training within the Regulatory team. To qualify for this position, you should have a University Degree in Science or a related discipline, along with 6-12 years of relevant regulatory experience in license maintenance, labelling, and working across various markets. Leadership skills, excellent English communication skills, and a thorough understanding of the regulatory product maintenance process are essential. Experience in working with diverse teams, especially in Europe and the USA, is preferred. Key skills and capabilities required for this role include supplier and partner management, project management, influencing, problem-solving, independence, teamwork, customer focus, and a commitment to continuous improvement. If you are passionate about regulatory affairs and possess the necessary qualifications and experience, we encourage you to share your profile with us at contact@covalenttrainings.com or contact us at +91-9848733309 / +91-9676828080 for further guidance. Join us at Covalent and contribute to maintaining regulatory compliance while fostering strong partnerships with internal and external stakeholders.,