Director of Regulatory Affairs

Reading , UK ( Hybrid ) Fleet, Bracknell, Maidenhead, Wokingham, Slough, Aldershot, Windsor

Basingstoke, High Wycombe, Farnham

Full Time

What you will d

o
The Director of Regulatory Affairs has an in-depth understanding of the regulatory environment within their geographical area of responsibility as well as requirements and strategies for regulatory submissions and approval pathways and the potential impact of these on business objective

• s.
  Leads the Cluster Regulatory Affairs team, ensuring successful local deployment of new product registrations, line extensions, new indications and claims in alignment with the business plan, while maintaining compliance for all products with local regulations and quality system requiremen
• ts.Provides strategic vision & creates an environment of operational excellence through regulatory expertise by managing and developing direct reports and collaborating with cross-functional teams to successfully achieve local/regional regulatory objectiv
• es.Management of the Cluster Regulatory Affairs team & oversight of associated regulatory sp
• endAssesses links between global, societal, public health and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strate
• gy.Develops and implements regulatory plans and strategies in alignment with agreed business plans and in compliance with applicable global and/or regional regulatory requiremen
• ts.Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcom
• es.Facilitates and cultivates external relationships, representing Client with the relevant regulatory agencies and industry & professional associations as requi
• redRepresents the Regulatory Affairs function as appropriate in Cluster and EMEA Regulatory Affairs Leadership te

ams

Essential duties and responsibil

ities
The Roles & Responsibilities in

clude:Regulatory St

• rategyProvides strategic input and technical guidance on local/regional regulatory requirements to product development
• teams.Assesses the acceptability of quality, preclinical and clinical documentation for submission filing to comply with applicable local Health Authority require
• ments.Monitors implementation of regulatory strategies relative to product and clinical safety issues iden
• tifiedProvides in-depth understanding and ability to incorporate regulatory strategies to expedite development, regulatory approval and/or market access of new pr
• oductsProvides regulatory guidance on strategy for proposed product claims/labeling and provided clinical and non clinical data, to ensure compliance with the local regulatory requirements and to optimise the proposed product posit
• ioningLeads key negotiations and interactions with regulatory authorities during all stages of the development and review p
• rocessPrepares cross functional teams for interactions with local regulatory authorities including scientific advice me
• etingsAdapts pre and post market strategy based on consideration of factors such as reimbursement, public health policies, state/provincial/regional restrictions and other local legislative/regulatory require

ments.
Regulatory Com

• plianceMaintains awareness of current regulations and anticipates implications and opportunities as a result of changes to the relevant regulatory environment. Communicates changes to appropriate management, advises internal stakeholders on a course of action and cross functional experts as appropriate, and oversees local impleme
• ntationNegotiates with regulatory authorities on complex issues throughout the product lif
• ecycle.Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures
• (SOPs).Oversees compliance of all product artworks and promotional materials for all local Client p
• roductsAccountable for ensuring that the enterprise Regulatory systems are accurate and fully mai
• ntainedEnsure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented
• locallyIdentifies local process improvement opportunities and ensures implementation of relevant global or regional regulatory init
• iativesManages and supports internal and external audits and inspections in collaboration with quality f

unction
Regulatory

• AdvocacyRemains up-to-date on scientific and clinical advances that impact healthcare product development and assesses the relationship to regulation and regulatory
• issues.Drive new approaches to improve the development, review and oversight of regulatory frameworks for healthcare products in their area of geographic respons
• ibility.Engages with external stakeholder groups to help shape science-based regulatory decision making as

requiredSpecific requ

• irements
  Relevant Bachelor's Degree
• or higher10+yrs related regulatory e
• xperienceExpertise across a broad spectrum of Regulatory classifications including Medicinal Products, Cosmetics, Commodities and/or Medica
• l DevicesSolid understanding of regulatory/medical/safety/quality requirements in the markets of
• relevanceProficiency i
• n EnglishExcellent knowledge of required regulatory frameworks including medicines, medical devices and dietary supplement regulation as
• a minimumExcellent personal and people l
• eadershipBroad knowledge of consumer healthcare environment and product de
• velopmentCore com
• petenciesExcellent communication skills, with the ability to articulate and express concepts clearly and persuasively both verbally and in writing, particularly when simplifying complex regulatory or technica
• l issues.Strong interpersonal skills; able to build effective personal networks internally and ex
• ternally.Highly collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering
• results.High degree of organizational and analytical skills, able to demonstrate sound judgment & develop creative
• solutionsIn-depth knowledge of the business, organizational goals, Regulatory Affairs function, and cross functional business partners to make informed business decisions and create and execute business strategies. Ability to represent RA function on cross-functional teams and governanc
• e forums.Able to work effectively in a multi-cultural, highly matrixed orga

nisation.