Regulatory Affairs Tactical & AI Manager

Praxy; Ciudad de México; Híbrido; MXN 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Bristol Myers Squibb is seeking a Regulatory Tactical Manager in Mexico City to convert strategy into executable tactical plans, manage submission calendars, and guide third parties in local regulatory processes.

The role emphasizes hands‑on dossier work, AI and automation adoption, and cross‑functional coordination with Marketing, Medical, Legal and Quality to ensure compliant, timely filings.

Formación

• 4–6 years of experience in Regulatory Affairs with hands‑on dossier work.
• Knowledge of COFEPRIS and CTD/eCTD standards.
• Experience guiding external partners or CMOs on regulatory documents.
• Strong project management and organizational skills.

Responsabilidades

• Own day‑to‑day governance mechanics and project trackers for the portfolio.
• Provide dossier compilation support and third‑party guidance to ensure timely submissions.
• Translate regulatory strategy into detailed tactical plans and timelines.
• Oversee AI and digital enablement within regulatory workflows.
• Coordinate cross‑functional activities across Regulatory, Marketing, Medical, Legal and Quality.
• Share best practices and mentor junior analysts in tactical planning and execution.

Conocimientos

Regulatory affairs

Dossier compilation

PM certification

AI/digital tooling

Cross-functional coordination

Technical communication

Leadership

Educación

Bachelor's in Life Sciences

Descripción del empleo

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Position Summary:

The Regulatory Tactical Manager is the operational engine of the Mexico regulatory function: it converts approved strategy into executable tactical plans, operates the day-to-day project governance mechanics (trackers, cadences, escalation logs) that support the Country Head's governance model, and provides hands-on technical execution — including direct dossier compilation support and technical/tactical guidance to third parties (distributors, licensing partners) responsible for local submissions. The role is also the function's operational owner for AI-enabled tools and digital automation, embedding practical use cases into daily regulatory work.

Duties/Responsibilities

• Own and operate the day-to-day governance mechanics — trackers, milestone dashboards, escalation logs — that put the Country Head's single-threaded governance model into practice for the assigned portfolio.
• Track dependencies, risks, and milestones across the portfolio, flagging deviations early enough for tactical correction before they require executive escalation.

2) Dossier Technical Execution & Third-Party Tactical Guidance

• Provide hands‑on technical compilation support for dossiers (new registrations, renewals, variations, CMC changes), assembling and quality‑checking content against COFEPRIS/eCTD requirements ahead of Senior Manager review.
• Act as the direct technical and tactical point of contact for third parties (distributors, licensing partners, external dossier compilator) responsible for local submission, guiding them on format, documentation completeness, and procedural requirements to prevent rework and delays.
• Escalate technical or strategic gaps identified during third-party interaction to the Senior Manager for resolution.

3) Tactical Planning & Submission Management

• Translate regulatory strategy approved by the Senior Manager/Country Head into detailed tactical project plans, timelines, and critical paths for filings, approvals, line extensions, renewals and variations.
• Own the tactical planning and orchestration of the registration and submission calendar for assigned product(s), consolidating renewal deadlines, variation triggers, and new registration timelines into a single portfolio view.
• Maintain a single source of truth for registration and lifecycle status across BMS RIM and other systems, ensuring data integrity for portfolio-level decisions.

4) AI & Digital Enablement

• Serve as the function's operational owner for AI-enabled tools and automation supporting regulatory intelligence, drafting support, and submission quality checks — administering day‑to‑day use, maintaining data hygiene in BMS RIM, and troubleshooting adoption issues.
• Identify and pilot practical AI/automation use cases at the execution level (e.g., dossier QC, tracking, intelligence synthesis), packaging results into recommendations for the Senior Manager/Country Head's capability roadmap; does not own the strategic technology roadmap or budget.
• Train and support team members and third‑party partners on adopting AI‑enabled tools and workflows.

5) Cross‑Functional Coordination

• Act as project manager for Advertisement/Promotional Materials and artwork/labeling processes, coordinating dependencies across Regulatory, Marketing, Medical, Legal and Quality.
• Serve as the day‑to‑day operational point of contact for cross‑functional partners on regulatory timelines and dependencies; strategic or senior‑stakeholder representation remains with the Senior Manager/Country Head.

6) Team Contribution & Development

• Share regulatory, project‑management, and technical dossier best practices with peer analysts; act as a proactive, well‑respected team resource.
• Support the development of analyst‑level colleagues on tactical planning, technical execution, and AI‑tool adoption

Qualifications & Experience

• -- Bachelor Degrees, Life Sciences, or related discipline.
• - 4–6 years of experience in Regulatory Affairs, including hands‑on dossier compilation/technical work within pharmaceutical or biotech sectors.
• - Working knowledge of COFEPRIS requirements and CTD/eCTD technical standards.
• - Experience guiding external partners, distributors, or CMOs on regulatory documentation is a plus.
• - Demonstrated project management skills; formal PM certification (e.g., PMP, CAPM) a plus.
• - Comfort with digital and AI‑enabled tools; experience piloting or adopting automation in regulatory workflows is a plus.
• - Strong organizational, cross‑functional coordination, and technical communication skills.

Key Competency Requirements:

• Knowledge of local regulatory processes, regulations and guidelines.
• Awareness of regulatory environment developments.
• Understanding of the drug development process from discovery to marketing.
• Good oral, written and communication skills in English.
• Leadership skills: good communication ability, strategical thinking.

#LI-Hybrid

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site‑essential, site‑by‑design, field‑based and remote‑by‑design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

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 [email removed]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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