Specialist, GRA, LRR Mexico, Region LATAM & Partner Business

The Opportunity:

Reporting to the Associate Director, Regulatory Affairs & Pharmacovigilance of our Mexico sales affiliate, as the Specialist, GRA, LRR Mexico, Region LATAM & Partner Business, you will focus on local regulatory requirements and Health Authority national engagements. Your key interactions will be with local external stakeholders, e.g., Health Authorities, local industry association(s), in-market commercial counterpart and Regional Regulatory Lead (RRL) counterparts in respective GRA (Global Regulatory Affairs) regions.

This is a hybrid role, which offers a combination of an onsite and remote work schedule. #LI-hybrid

The Role:

Strategy (execution) and management

• Provide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activities; monitor and report progress consistently to stakeholders.
• Ensure strict compliance with local regulations, actively participating in policy activities with industry groups and trade associations. Act as RA representative in audit/inspection and ensure readiness and timely CAPA closure in alignment with other functions.
• Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulation and subsequently communicate requirements to GRA and local staff; participate actively in regulatory meetings, forums, and conferences to stay informed share insights and best practices within the organization.

• Act as primary interface with local HAs, industry groups, and trade associations, representing the company's regulatory interests and fostering positive relationships; lead in-country regulatory processes, acting as the final contact point with HAs for licenses, partner regulatory licenses, and market access collaborations.
• Prepare, organize and coordinate local specific documentation e.g. module 1 to meet national submission requirements and be responsible for keeping up-to-date local national systems as per local legislation.
• Provide critical support for implementation of local legislation , promotional material review, interpretation of regulations and regulatory agency expectations as well as lead regulatory strategies for product launches and integrations at affiliate level.
• Support regional regulatory TA teams within GRA, for efficient planning and submission preparation according to local requirements and business needs; monitor status of submitted regulatory activities with local health authorities.
• Act as primary RA representative for local ComOps: adopt a business perspective, explore opportunities and translate this thinking into actionable plans that fit with strategy.
• Keep RIMS up to date with local activity and ensure compliance KPIs are adequately kept on track.
• Ensure compliant labeling (SmpC, PIL, packaging) and manage timely updates including translation, and promotional material review.

• 3 to 5+ years of (local) regulatory knowledge and experience in a regulatory authority facing role; i.e. comprehensive understanding of regional and global regulatory requirements, guidelines and processes.
• In-depth expertise on local health authority management.
• Required fluency in Spanish and English, oral and written, to include the ability to read and write emails and communicate effectively with global colleagues.
• Project management skills and leadership skills; i.e. proven experience in managing e.g., regulatory submissions, timelines and cross-functional teams to ensure timely and successful product registrations and compliance.
• Experience in managing ComOps Stakeholders: matching influencing style to stakeholders to maximize impact and effectiveness of GRA expertise, proactively identifying opportunities to influence stakeholders on business critical decisions and employing a systematic approach to influence key internal stakeholders based on business needs and objectives.
• Experience in successfully dealing with rapid change.
• Expert MS Office skills.
• Excellent organizational, time management and interpersonal skills in a global environment.
• Ability to work successfully in a complex global matrix organization.
• Proven ability to work effectively both independently and in a team.
• The expertise, determination and courage to resolve or escalate issues as appropriate.
• subject matter expert in job area typically obtained through advanced education and work experience.