PE Global
Regulatory Affairs Specialist
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Regulatory Affairs Specialist - CMC - 6-Month Contract
PE Global are currently recruiting for a Regulatory Affairs Specialist - CMC- for a 6-month contract role with a leading multinational Consumer Health client based in Reading – hybrid (2/3 days per week in the office).
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 anticipates 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.
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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.
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Interested candidates should submit an updated CV.
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