Director of Regulatory Affairs in Reading

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 requirements.

• 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 objectives.

• es. Management of the Cluster Regulatory Affairs team & oversight of associated regulatory sp
• end Assesses 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 requirement

• ts. Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcome
• es. Facilitates and cultivates external relationships, representing Client with the relevant regulatory agencies and industry & professional associations as requ
• red Represents the Regulatory Affairs function as appropriate in Cluster and EMEA Regulatory Affairs Leadership te ams
  Essential duties and responsibil ities clude: Regulatory St
• rategy Provides 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 requirements.
• Monitors implementation of regulatory strategies relative to product and clinical safety issues identified.
• Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development, regulatory approval and/or market access of new products.
• Provides regulatory guidance on strategy for proposed product claims/labeling and provided clinical and nonclinical data, to ensure compliance with the local regulatory requirements and to optimise the proposed product position.
• ioning Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process.
• Prepares cross functional teams for interactions with local regulatory authorities including scientific advice meetings.
• etings Adapts 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 requirements.
• ments.
  Regulatory Com
• pliance Maintains 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

• ntation Negotiates 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 products Accountable for ensuring that the enterprise Regulatory systems are accurate and fully maintained.
• ntained Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented.
• locally Identifies local process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives.
• iatives Manages and supports internal and external audits and inspections in collaboration with quality f unction
  Regulatory
• Advocacy Remains 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 required Specific requ
• irements
• Relevant Bachelor's Degree
• or higher10+yrs related regulatory e
• xperience Expertise across a broad spectrum of Regulatory classifications including Medicinal Products, Cosmetics, Commodities and/or Medica
• l Devices Solid understanding of regulatory/medical/safety/quality requirements in the markets of
• relevance Proficiency i
• n English Excellent knowledge of required regulatory frameworks including medicines, medical devices and dietary supplement regulation as
• a minimum Excellent personal and people l
• eadership Broad knowledge of consumer healthcare environment and product de
• velopment Core com
• petencies Excellent 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
• solutions In-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.
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