Regulatory Affairs Specialist

JR United Kingdom; High Wycombe; Hybrid; GBP 40,000 - 70,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Specialist for a contract role in High Wycombe. This exciting opportunity involves developing regulatory strategies across the EMEA region, providing technical guidance to product development teams, and ensuring compliance with local regulations. The ideal candidate will have a strong background in pharmaceutical CMC regulatory affairs and a relevant Bachelor's degree. Join a dynamic team and play a pivotal role in shaping product strategies while navigating the complexities of regulatory environments. If you are passionate about regulatory affairs and looking for a challenging yet rewarding position, this role is for you.

Qualifications

• Expertise in pharmaceutical CMC regulatory affairs.
• Knowledge of EU regulatory frameworks and environments.

Responsibilities

• Provide strategic regulatory input to product development teams.
• Prepare and submit regulatory submissions in EMEA.
• Ensure compliance with local regulatory and quality system requirements.

Skills

Regulatory Affairs

Technical Guidance

Regulatory Submissions

Compliance Management

Cross-functional Collaboration

Education

Bachelor's Degree in Relevant Field

Job description

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Regulatory Affairs Specialist, high wycombe

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Client:

PE Global

Location:

high wycombe, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

3

Posted:

05.05.2025

Expiry Date:

19.06.2025

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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.

• Participate in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs and working instructions.

• Ensures that the enterprise Regulatory systems are accurate and fully maintained.

• Ensures 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

• Relevant Bachelor's Degree or higher

• Expertise across a broad spectrum of Regulatory classifications including Drugs, Dietary Supplement and/or Medical Devices, mainly pharmaceutical CMC regulatory affairs

• 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.

• Solid understanding of regulatory CMC in the markets of relevance

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***