Regulatory CMC Consultant

JR United Kingdom; High Wycombe; Hybrid; GBP 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Consultant to lead regulatory strategies across the EMEA region. This role involves providing strategic input, managing submissions, and ensuring compliance for various products. You will collaborate with cross-functional teams, driving operational excellence while leading a dedicated team. This position offers a unique opportunity to influence product development and navigate the complexities of regulatory environments. If you are passionate about regulatory affairs and eager to make a significant impact, this role is perfect for you.

Qualifications

• Expertise in regulatory classifications including Drugs, Dietary Supplements, and Medical Devices.
• Solid understanding of regulatory CMC in relevant markets.

Responsibilities

• Develop regulatory strategies and provide guidance on regional requirements.
• Manage regulatory submissions and ensure compliance with local regulations.
• Lead a team to achieve regulatory objectives and support product development.

Skills

Regulatory Affairs

CMC Expertise

Project Management

Cross-functional Collaboration

Regulatory Compliance

Education

Bachelor's Degree

Job description

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Job title: Regulatory Affairs Consultant, CMC

Reporting to: Senior Manager, CMC

Functional group: EMEA Regulatory Affairs (R&D)

Location: High Wycombe, United Kingdom – Hybrid (2/3 days per week in the office)

Cpl Life Sciences are collaborating with a leading consumer health business who are looking for a Regulatory CMC Consultant on a 6-month basis.

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.

• Leads a Regulatory Affairs team ensuring the success of new product registrations, line extensions and new indications and claims with supportive technical justification/documentation in alignment with the business plan.
• Create an environment of operational excellence through regulatory expertise by managing direct reports and collaborating with cross-functional teams to successfully achieve regulatory objectives.
• Manages the global &/or regional regulatory deliverables for drugs, dietary supplements & medical devices as relevant, within their brand area & geographic responsibility.
• Develops strong partnerships with Regulatory Affairs Franchise, R&D, Marketing, Supply Chain and local business representatives.
• Represents the Regulatory Affairs CMC function as appropriate in Self Care Franchise, functional and business Leadership teams

The Roles & Responsibilities include:

• 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.

Regulatory Compliance

• 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
• 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

Team Management:

• Evaluates deliverables of self/direct reports against set timelines, acting where necessary to minimize delays and anticipate difficulties/risks.

Specific requirements

• Partners with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility.

Job 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