Sr Regulatory Affairs Manager

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 lifecycle 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. Preferred Attributes Commercial experience and exposure to market access strategies. Success in health authority interactions and global dossier preparation. 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. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. 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. We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. 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/ #J-18808-Ljbffr