Sr Regulatory Affairs Manager

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. 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 .

Bristol Myers Squibb es un empleador que brinda igualdad de oportunidades. Las personas que apliquen para cualquier vacante, y que estén calificadas para la misma recibirán consideración para el empleo sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, nacionalidad, edad, discapacidad, condición de veterano protegido, embarazo, ciudadanía, estado civil, expresión de género, información genética, afiliación política o cualquier otra característica protegida por la ley.

Position Summary

The Regulatory Senior Manager is responsible for developing and executing regulatory strategies that ensure timely product approvals and compliance with local and global regulations. This role provides leadership across cross-functional teams, guiding submissions for new registrations, variations, and life-cycle management activities through robust risk assessments and informed decision-making . The position requires strong collaboration and clear communication with health authorities and internal stakeholders to anticipate regulatory challenges, maintain governance standards, and support business objectives. Additionally, the Regulatory Senior Manager drives operational excellence, fosters team development, and ensures adherence to company policies and regulatory requirements throughout the product lifecycle.

Key Responsibilities
Health Authority Engagement
Act as primary liaison with COFEPRIS and other regulatory agencies.
Lead formal meetings to explore opportunities to expedite approvals and resolve queries.
Build strategic planning and execution in partnership with the Associate Director to enhance and elevate strategic opportunities
Anticipate regulatory trends and proactively adjust strategies to mitigate risks or find opportunities.
Oversee preparation, review, and timely submission of dossiers (MAA, line extensions, renewals, CMC changes).
Ensure compliance with eCTD standards, ICH guidelines, and local regulations.
Maintain robust documentation and audit readiness for all regulatory activities.
Conduct regulatory risk assessments for projects and propose mitigation plans.
Make informed decisions on reliance pathways and expedited procedures.
Manage end-to-end lifecycle activities: labeling updates, post-approval changes, and renewals.
Apply best practices for regulatory lifecycle management to optimize compliance and reduce rework.
Represent regulatory affairs in cross-functional teams.
Partner with Clinical, Supply Chain, Pharmacovigilance, and Market Access teams for integrated execution.
Implement Regulatory Information Management (RIM) systems and automation for submissions.
Drive continuous improvement initiatives to streamline workflows and reduce compliance risks.
Collaborate with industry associations to advocate for science-based regulatory policies.
Participate in shaping the regulatory framework by contributing to consultations, working groups, and technical committees.
Monitor and influence evolving regulations to create a favorable environment for innovation and patient access.
Mentor junior staff and build regulatory capabilities for future business needs.
Act as deputy for the Associate Director when required.
Qualifications & Experience
Bachelor's degree in Pharmacy, Life Sciences, Medicine, or related discipline.
Advanced degree (MS, PharmD, or MBA) preferred for strategic roles
Minimum 8 - 10 years in Regulatory Affairs within pharmaceutical, biotech sectors.
Proven track record in regulatory submissions (MAA, lifecycle management) and successful product approvals.
Experience managing portfolio lifecycle (launch, growth, maturity) and more than 3 product launches or new indications.
2+ years of people management experience preferred
Deep understanding of drug development process from discovery to marketing.
Familiarity with ICH guidelines, eCTD standards, and local regulatory frameworks (FDA, EMA, COFEPRIS).
Knowledge of CMC regulatory requirements and lifecycle management.
Strategic Thinking: Ability to develop and execute regulatory strategies aligned with business objectives.
Risk Assessment & Decision-Making: Skilled in identifying regulatory risks and proposing mitigation plans.
Cross-Functional Leadership: Experience leading matrix teams and influencing senior stakeholders.
Negotiation & Communication: Strong ability to engage with Health Authorities and internal teams effectively.
Additional Skills
Project Management: Proven ability to manage complex projects under tight timelines.
Adaptability: Thrive in dynamic environments and manage ambiguity.
Digital Proficiency: Familiarity with Regulatory Information Management (RIM) systems and electronic submission tools.
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Preferred Attributes
Commercial experience and exposure to market access strategies.
Success in health authority interactions and global dossier preparation.
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™ , 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 a supportive culture, promoting global participation 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 an 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.

Supporting People with Disabilities

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.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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