Sr Regulatory Affairs Manager

Bristol Myers Squibb•Winter Haven, FL

About The Position

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.

Requirements

Bachelor’s degree in Pharmacy, Life Sciences, Medicine, or related discipline.
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.
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.

Nice To Haves

Advanced degree (MS, PharmD, or MBA) preferred for strategic roles
Commercial experience and exposure to market access strategies.
Success in health authority interactions and global dossier preparation.

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.