Job Description

Working with Us

Challenging. 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 .



Position Summary:



Managing the regulatory aspects of projects and products for pre-approval and post approval submissions for biological, new drugs and global and local clinical trials. In addition, participating in project team meetings, by providing regulatory support to ensure compliance with all local requirements.



Roles and Responsibilities: • To manage and execute coordination, compilation and review all marketing and import registration applications and Clinical Trial applications including maintenance applications.
• Responsible for complying the regulatory processes in line with business/R&D objectives to ensure timely registration of new drugs/biologics, new/additional dosage strengths/forms, manufacturing site, support import license, renewal registrations, withdrawals, etc. for commercialized products
• Participate in site to market meetings to support commercial launch.
• Execute day to day regulatory operational task.
• Regulatory collaboration with Medical and Marketing to deliver on regulatory commitments.
• Drives regulatory collaboration with Medical, Business, Supply Chain, QA teams in order to deliver on regulatory commitments.
• Execute local, regional and global initiatives in order to deliver on regulatory commitments.
• Collaboration with regulatory affiliates/local partners in markets within the responsibility in order to deliver on commitments
• Engagement with the regulatory partners in markets within the responsibility, through periodic meetings to achieve BMS business objectives.
• Drives regulatory collaboration with Supply groups and artwork teams in order to ensure uninterrupted access of drugs to patients.
• Executes all regulatory activities including labelling in the region to achieve regulatory compliance.
• Liaises with the global team and the local partners to compile submission ready dossiers (paper and electronic) as per the local regulation to achieve timely HA submissions/approvals in markets within the responsibility.
• Drives implementation of standardized good regulatory practices in the region, ensuring regulatory SOPs are in place and appropriate trainings are taken as necessary.
• Update regulatory archives (VERITY), share points.
• Participate in audits as required.
• Responsible for assuring that approved labelling (PIL, PI, pack) is implemented in production in accordance with local legislation.
• Drives and support local projects and department related assignments.
• Responsible to keep up to date with the regulatory environment within the industry.
• Develop and interact with health authorities and industry bodies from BMS product perspective.
• Involved in Budget preparation.
• Can deputize the GRS lead in external and internal shareholder engagement as required.
• Support the GRS lead in mentoring and continuous development of the team.
• Provide regulatory and product compliance expertise in the area of promotional inputs, ARRM and label claims for existing and new products.
• Ownership of creating India specific packs, with no disruption in excess of medicines to patients.
• Core member representing regulatory in the IO and Hematology discussions, sharing regulatory strategies and updates.
• Accountable to share regulatory inputs in site to market meeting with the supply chain to facilitate smooth commercial launches.
• Manage the regulatory affairs personnel to keep close track of evolving regulations, ongoing regulatory activities

Qualification and Experience Required: • Required degrees, certifications, and/or licensure relevant to role- Bachelor's degree or master degree in Science equivalent or BPharm or MPharm
• Professional experience with 5-10 years of relevant regulatory experience

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 Careers

With a single vision as inspiring as Transforming patients' lives through science(TM) , 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 Protocol



BMS 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 workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to 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.