Regulatory Affairs Manager, 12 month FTC
- 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.
- 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
- 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.
- Bachelor’s degree in Pharmaceutical Sciences
- Advanced written and spoken English and knowledge of Spanish will be considered an advantage
SKILLS & EXPERIENCE:
- 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)
- 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.
- 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
- Problem Solving
- Proactively identify risks and develop potential solutions
- Ensuring assigned projects are appropriately prioritised and progressed in accordance with agreed regulatory plans
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.