Regulatory Strategy Senior Manager

Location: City of Westminster

Regulatory Strategy Senior Manager page is loaded## Regulatory Strategy Senior Manager locations:
Paddington, United Kingdom time type:
Full time posted on:
Posted Todayjob requisition :
REQ-27608
** Job Description
**** General

Summary:

*** Reporting to the Director Regulatory Affairs, Distributor Markets & Geographic Expansion Lead, the RoW Senior Manager (SM) will lead and support submissions in Distributor Markets for MAAs and license maintenance.
* The SM will provide local expertise as a member of the Global Regulatory Affairs (GRA) team to ensure Vertex establishes and implements best practices
** Key

Duties and Responsibilities:

**** Regulatory
* ** Acts as main contact for submission partners i.e. GCC (KSA, UAE, Kuwait, Bahrain, Qatar, Oman), Russia, Israel, Serbia, North Macedonia, Jordan and additional countries added by the Global Expansion Team
* 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, exemption from local labelling, 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
** Knowledge and

Skills:

**** Regulatory
* ** Relevant industry experience in regulatory affairs, across the lifecycle, and understanding of current trends in local and regional requirements.
* Recognized as a knowledgeable resource for regulatory advice by other departments
* Experience of managing negotiations 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.
* Ensuring assigned projects are appropriately prioritised and progressed in accordance with agreed regulatory plans.
* 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.
* Proactively identify risks and develop potential solutions
* 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.
* Fluent written and spoken English.
*
* Education and Experience:

*** Bachelor’s degree in life sciences or M.Sc. or Ph.D. degree
* Typically requires solid experience in relevant pharmaceutical or biotech industry…