Job Description
PE Global are currently recruiting for a Regulatory Affairs Specialist -CMC- for a contract role with a leading multinational Consumer Health client based in High Wycombe (hybrid).
Responsible for the development of CMC/technical regulatory strategies across the EMEA region providing regulatory input and technical guidance on regional regulatory requirements to product development teams within the Self Care franchise.
Responsibilities
• Provides strategic regulatory input and technical guidance on regional regulatory requirements to product development teams.
• Supports the business initiatives, by strengthening propositions, influence and acts as strategic advisor on brand/need state portfolio forums.
• Participates in cross-functional project teams to define development program requirements and risks.
• Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines in EMEA.
• Maintains awareness of current regulations and anticipate implications and opportunities because of changes to the relevant regulatory environments.
• Communicates changes to appropriate management and cross functional experts as appropriate.
• Ensure that all products comply with local regulatory and quality system requirements.
• Ensures quality and compliance in all actions.
• Parti...