Regulatory affairs specialist

PE Global are currently recruiting for a Regulatory Affairs Specialist for an initial 6 month contract role with a leading multinational Consumer Health client based in Reading – hybrid (2/3 days per week in the office).

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 stakeholders within LCM and growth & innovation.
• 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.
• Participate in the development and implementation of, and maintains compliance with, all applicable Processes.
• Ensures that the enterprise Regulatory systems are accurate and fully maintained.
• Ensure any compliance issues are reviewed and escalated, and relevant corrective/preventative actions are implemented locally.
• Identifies and/or implements regional process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives.
• Evaluates deliverables of self/direct reports against set timelines, acting where necessary to minimize delays and anticipate difficulties/risks.

Requirements

• Requires 6-8 Years Work Experience
• Relevant Bachelor's Degree or higher in Life Science or Chemistry/Biology.
• Expertise of EU WS and MR-DC in line with the Pharmaceutical Directive and associated guideline.
• Specific skills in management of EU procedures are a must.
• Desirable to have experience in leading early-stage innovation RA deliverables such as determine classification status, regulatory strategy for medicinal products and implementation of the strategy.
• Knowledge of regulatory frameworks and external environments in the EU and wider EMEA, and the ability to apply these to regulatory solutions throughout the product lifecycle.
• Strong project management skills.

Interested candidates should submit an updated CV.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***