Manager, Global Regulatory Cmc EMEA

Submission for the position: Manager, Global Regulatory CMC EMEA - (Job Number: 2407026778W)

Job title: Manager Regulatory Affairs (CMC)

Reporting to: Associate Director Regulatory Affairs (CMC)

Functional group: EMEA Regulatory Affairs (R&D)

Location: United Kingdom

Job Description

Job purpose

The Manager Regulatory Affairs (RA) is 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.

Key Responsibilities

• 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.
• Creates 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, Franchise (Marketing), and local business representatives.
• Facilitates and cultivates external relationships, representing Kenvue with the relevant regulatory agencies and industry & professional associations as required.
• Represents the Regulatory Affairs CMC function as appropriate in Self Care Franchise, functional and business Leadership teams.

Essential Duties and Responsibilities

Regulatory Strategy

• Provides strategic regulatory input and technical guidance on global and/or regional regulatory requirements to product development teams.
• Supports the business initiatives by strengthening propositions, influencing, and acting as a strategic advisor on brand/need state portfolio forums.
• Provides regulatory risk-based assessment and guidance for proposed product claims/labeling, ensuring that the provided clinical and non-clinical data are consistent with the required regulatory requirements and support the proposed product positioning and claims.
• Participates in cross-functional project teams to define RA resources, development program requirements, and risks.
• Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
• Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at the regional level.

Regulatory Compliance

• 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.
• Ensures that all products comply with local regulatory and quality system requirements.
• Ensures quality and compliance in all actions.
• Participates 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.
• Identifies and/or implements global/regional process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives.
• Supports internal and external audits and inspections in collaboration with the quality function.
• Supports crisis management / PR matters as related to regulatory affairs.

Regulatory Advocacy

• Monitors the regulatory environment and provides assessments of the impact of new and changing regulations on the company’s areas of interest.
• Actively participates in trade associations, working groups, developing impact assessments, influencing strategies, and leading solutions at the regional level (if relevant).

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 the area of responsibility.

Other Features of the Job

• Represents Regulatory Affairs on cross-functional product/project teams and provides regulatory advice.
• Manages work groups and provides direction.
• Provides day-to-day instructions and suggested training activities to direct reports.
• Applies organizational understanding and awareness in decision-making.
• Uses effective communication and employs influencing skills to continue to grow key relationships with internal/external contacts.
• Builds and guides team and develops direct reports.
• Recruits high-caliber professionals and contractors to strengthen the business talent.

Essential Knowledge and Skills

• Relevant Bachelor's Degree or higher.
• Expertise across a broad spectrum of Regulatory classifications including Drugs, Dietary Supplement, and/or Medical Devices.
• Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions throughout the product lifecycle.
• Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance.
• Leadership and coaching skills.
• Proficiency in English.

Core Competencies

• Excellent communication skills, with the ability to articulate and express concepts clearly and persuasively both verbally and in writing, particularly when simplifying complex regulatory or technical issues.
• Strong interpersonal skills; able to build effective personal networks internally and externally.
• Highly collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results.
• Strong organizational, people, and time management skills with an ability to work under pressure.
• Demonstrable commercial focus and business acumen which will enable them to thrive in a fast-paced, dynamic, results-driven environment.
• Able to work effectively in a multi-cultural, highly matrixed organization.
• Proficiency in English.