Senior Regulatory Affairs Professional

4 days ago

bharatpur, India beBeeRegulatoryAffairs Full time

We are seeking an experienced professional to fill the role of Senior Regulatory Affairs Associate. The ideal candidate will have a strong background in handling new registration, life cycle management, renewals of Biologicals, Vaccines, recombinant protein molecules, monoclonal antibodies, plasma derived and small molecules in various markets.Key ResponsibilitiesThe successful candidate will contribute to the preparation and delivery of regulatory submissions from a global and regional perspective.Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada Switzerland, Australia is also required.A good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions is necessary.The role requires a high level of expertise in global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries. Knowledge of regulatory affairs is essential for success in this position.Requirements3+ years of experience in regulatory affairs with a focus on biologicals, vaccines, recombinant protein molecules, monoclonal antibodies, plasma derived and small molecules.Strong knowledge of regulatory frameworks, including ICH guidelines and regional trends.Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.BenefitsThis is an excellent opportunity to join a dynamic team and make a meaningful contribution to the organization's success.Competitive salary and benefits package.About UsWe are a leading organization in the field of pharmaceutical development and regulation.

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