Job Description

POSITION SUMMARY:

• The Regulatory Affairs (RA) Specialist works with the EU Regional Regulatory Lead (RRL) and Global Regulatory Lead (GRL) to coordinate the development and implementation of regulatory strategy for specific programmes
• This individual will be responsible for managing regulatory submissions, e.g. CTAs, PIPs, orphan designation applications and national Managed Access Plans (MAPs - early access/compassionate use programs), and may also support complex regulatory submissions, e.g., MAAs and new therapeutic indications

KEY RESPONSIBILITIES:

Regulatory

• Acts as the Regional Regulatory Support (RRS) for assigned product(s)
• In collaboration with RRL and GRL, develops regulatory strategy for assigned projects
• Coordinates and manages all Regulatory Affairs-related clinical trial activities, including:

• Initial CTA submissions and maintenance through to study completion, including oversight of external CROs/consultants where appropriate
• Regulatory input into the study set-up, including country feasibility and ensuring adherence to local requirements and legislation
• Coordinates & ensures timely completion of regulatory reviews of all clinical study documents requiring regulatory input (e.g. study protocols and amendments, IB, etc.)
• Ensures all agency correspondence and commitments are appropriately tracked and archived in accordance with Vertex procedures
• May support RRL and/or GRL to prepares and/or coordinates region/country specific regulatory documents for submission to regulatory agencies (e.g. Module 1 for complex regulatory submissions, orphan designations, scientific advice briefing materials, PIPs, etc.)
• Ensure projects are appropriately prioritised and progressed in accordance with agreed regulatory plans, with any identified risks (from emerging data, changing internal objectives or external threats) communicated to RRL, and potentially RA Senior Management, in a timely manner
• Manage the preparation and submission of regulatory submissions, with some supervision, for assigned products in line with regional regulatory requirements
• Keeps RRL informed of status of assigned responsibilities, including assessing and communicating changes and/or risks in a timely manner
• Supports region-specific Regulatory Authority interactions as needed
• Ensure all work is compliant with regulatory requirements and company policies and procedures

General

• Work with cross-department (e.g. Clincal Study Teams) and departmental (e.g Global Regulatory Subteams) teams to achieve corporate and departmental goals and objectives.
• Exhibit ownership and accountability for some projects and internal assignments
• Able to plan, schedule and arrange own work activities with direction from line manager
• Occasional travel may be required
• Hybrid role - 3 days per week in the office

EDUCATION:

• Bachelor\xe2\x80\x99s degree in life sciences required

SKILLS & EXPERIENCE:

Regulatory

• Experience of regulatory submissions such as CTAs, Type I variations
• Awareness of European regulatory landscape, including ICH and regional requirements for assigned territories and current regulatory trends

General

• Desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society
• Understands the need to 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
• Embraces being part of a team and working collaboratively with others
• Developing interpersonal skills and ability to deal effectively with a variety of personalities
• Able to convey requirements through or oral/written presentation skills.
• Fluent written and spoken English

EXPERTISE

Business and Management Expertise

• Interest in regulatory affairs with basic knowledge of EU regulatory environments and respective stakeholders (e.g., EMA, National Competent Authorities, etc.)
• Awareness of pharmaceutical development including the product lifecycle (development, MAA, post-authorization)

DELIVERING SOLUTIONS

Problem Solving

• Proactively identify risks and works with RRL to develop potential solutions

IMPACT

Accountability

• Ensuring assigned projects are appropriately prioritised and progressed with some supervision
• Exemplify Vertex\xe2\x80\x99s core values in fulfilling these job duties

#LI-Hybrid #LI-MS1

Company Information

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.

Vertex Pharmaceuticals