Executive - Regulatory Affairs

Executive - Regulatory Affairs - Mumbai Company overview: Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We welcome innovation—bringing ideas, products and services to life to advance the health and well-being of people around the world. We believe in collaboration, and that has led to breakthrough after breakthrough, from medical miracles that have changed lives, to the simple consumer products that make every single day a little better. Our over 125,000 employees in 60 countries are united in a common mission: To help people everywhere live longer, healthier, happier lives. In India, J&J operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices, which are independently handled and report into their respective Global business segments PHARMA: Janssen, the pharmaceutical division of Johnson & Johnson, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neurosciences & analgesia, dermatology, infectious diseases and metabolic diseases in India. Driven by a strong commitment to the health and well-being of patients, Janssen India brings innovative products, services and solutions to people throughout the world. Janssen recognizes the impact of serious conditions on people’s lives, and aims to empower people through disease awareness, education and access to quality care in six therapeutic areas. Johnson & Johnson companies are equal opportunity employers - The Global Job Posting policy promotes the dedication to the advancement and development of our employees. We invite you to read this posting and apply if you are passionate about the position and meet the requirements. JOB PROFILE DIVISION: Johnson & Johnson Pharmaceuticals (Janssen India) LOCATION: HO, Mumbai POSITION: Executive - Regulatory Affairs REPORTING TO: Manager – Regulatory Affairs JOB DESCRIPTION: • Compilation of documents for Registration of Drugs • Liaise with regional team for supporting documents and dossiers for product registration and for tenders • Provide inputs of regulatory affairs and ensure HA submissions for PMS and Phase IV studies: Quarterly and six-monthly study reports for PMS studies, clinical reports stability protocols and non-clinical study reports • Coordination with Regulatory Consultants for the effective submission of application at DCGI • Archival of dossiers, Approvals and DCGI submission copies • Providing support in Life Cycle management of registered products • Managing trackers and supporting tenders by providing various documents from regulatory perspective. Qualifications Minimum required Qualification / Experience / Exposures Bachelor’s degree or Master’s degree in Science / Pharma Minimum experience of 1 -3 years of Pharmaceutical sales with validated performance track record. How to Apply? Internal Applicants: If you wish to apply, please consider the following information from our Policy: We require you to have spent at least 18 months in your current position, and in good standing. As our employee you may apply for a position without informing current manager. However, when invited to interview, then, to the extent that this is consistent with local law or practice, you are required to notify your manager prior to the interview. This notification is inspired to promote development discussions between the managers and our employees. If you want to refer external talent for this position, please review our Global Referral Policy and submit your referral through My Career Opportunities by following the appropriate process. (Applicable only for Internal postings). External Applicants: Login to careers.jnj.com, search job matching you profile by location, keywords, requisition number. Primary Location India-Maharashtra-Greater Mumbai- Organization Johnson & Johnson Private Limited (8080) Job Function Regulatory Affairs Requisition ID 2105996948W