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Job Description

POSITION SUMMARY:

• Reporting to the Director, Regulatory Affairs, LATAM, the Regulatory Affairs Manager (RM) will lead and support submissions in Latin American Markets for MAAs and life-cycle management procedures.
• The RM will provide local expertise as a member of the Global Regulatory Affairs (GRA) team to ensure Vertex establishes and implements best practices.

KEY RESPONSIBILITIES:

Regulatory

• Lead cross functional Vertex team to prepare submission activities from the planning phase through to submission and review, including preparing responses to questions.
• Act as support to submission lead by preparing timelines and creating submission binders in Veeva and ensuring submission and correspondence files are up to date.
• Provide local regulatory expertise, maintain current knowledge of local requirements and anticipate, assess and communicate changes to local and RA Senior Management in a timely manner.
• Act as local expert for regulatory queries coming from other functions, e.g. medical and supply chain, on topics such as compassionate use, local labelling, GMP inspections, CTA requirements, etc.
• Ensure all work is compliant with regulatory requirements and company policies and procedures

General

• As applicable, support and contribute to local cross-functional and leadership teams to achieve corporate and departmental goals and objectives.
• Exhibit ownership and accountability for all projects and internal assignments; plan, schedule and arrange own work activities with limited direction.
• Attend meetings at local or international Vertex Offices.
• Exemplify Vertex’s core values in fulfilling these job duties.

EDUCATION:

• Bachelor’s degree in Pharmaceutical Sciences
• Advanced written and spoken English and knowledge of Spanish will be considered an advantage

SKILLS & EXPERIENCE:

Regulatory

• Relevant industry experience in regulatory affairs and understanding of current trends in local and regional requirements.
• Recognized as a knowledgeable resource for regulatory advice by other departments
• Experience of interacting with Regulatory Authorities
• Must be able to facilitate interactions with International Regulatory Affairs, other departments within the Company and external parties (mainly submission partners)

General

• Desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society.
• Good interpersonal skills and ability to deal effectively with a variety of personalities.
• Strategic ability, as evidenced by an awareness of the "big picture" strategic issues facing the business overall and positioning of local strategy relative to global and international requirements
• Self-motivated with the ability and desire to take on new challenges, to help build an organization and still be part of a team taking a hands-on approach to projects.
• Team player, but also able to behave independently where needed, at the same time this individual must understand and embrace being part of a team and working collaboratively with others.
• Strong analytical ability; and an ability to deal with ambiguity, uncertainty and complexity.
• Display solid ethics and fully comply with all regulatory, legal and industry codes of conduct.
• Ability to navigate and be successful in a fast-paced environment while delivering high quality results.
• Excellent communication skills, strong oral/written presentation skills.

EXPERTISE

• Business and Management Expertise
• Experience in regulatory affairs with track record of success
• Experience across the life-cycle (development and post-authorization).
• Specialized knowledge of local regulatory environments and stakeholders

DELIVERING SOLUTIONS

• Problem Solving
• Proactively identify risks and develop potential solutions

IMPACT

• Accountability
• Ensuring assigned projects are appropriately prioritised and progressed in accordance with agreed regulatory plans

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