Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more:careers.bms.com/working-with-us.The key objective of this role is to drive Regulatory department performance in order to deliver timely regulatory submissions (paper / electronic) and approvals, while promoting integrity, transparency and proactive communication of expectations to stakeholders, for regulatory activities like, but not restricted to:New drugs/biologics, subsequent new drugs/biologics, new/additional dosage strengths/forms, manufacturing site, import license registration/renewal registration; withdrawals, etc. for commercialized productsPost-approvalvariations/amendmentslike CMC, CCDS (i.e. package inserts) and labelling, manufacturing site, company registered address etc. for commercialized productsStudy protocol, protocol amendments, test license, investigation sites, periodic study reports etc. for clinical trialsHealth Authority commitments and queriesLeading the regulatory team in India and active member in India operating committeeExperience required:Appropriate basic graduation (e.g. degree in Pharmacy or in other Life Sciences), Post graduate degree in pharmacy/ life science preferred with 3-5 years consolidated experience inleading Regulatory Team.5-10 years of core functional regulatory knowledge an of which 3- 5 years of experience in leading the country regulatory teamExposure to international regulatory environment and capability to adapt the regulatory organization and implement appropriate plans.Proven experience and ability to manage people and cross functional groupsDemonstrated track record of developing teams and creating working systems and processesAbility to negotiateFluency in EnglishWillingness to travel (approx.20% of working time, to Delhi)If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as "Transforming patients' lives through science™ ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application, or in any part of the recruitment process, direct your inquiries ******. Visitcareers.bms.com/eeo-accessibilityto access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
