Regulatory CMC Consultant

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.
• Strong project management skills.
• Proficiency in English.