Job Information
J&J Family of Companies Senior Manager, Regulatory Affairs, CMC in England, United Kingdom
Senior Manager, Regulatory Affairs, CMC - 2407021125W
Description
Senior Manager, Regulatory Affairs, CMC
Located: High Wycombe, UK (Hybrid)
Who we are
At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent. Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours.
What will you do
The Senior Manager Regulatory Affairs (RA) leads a team 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 and developing 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.
Key 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, influence and acts as 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 regional level.
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 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 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 participate in trade association, working groups, developing impact assessments, influencing strategies, and leading solutions at regional level (if relevant).
Team Management
Provides technical and leadership development & coaching to build high performing team
Evaluates deliverables of self/direct reports against set timelines, acting where necessary to minimize delays and anticipate difficulties/risks.
Additional Responsibilities
Partners with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility.
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.
Represent the Senior Director/Director Regulatory Affairs (CMC) as delegate on request.
Qualifications
What we are looking for
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 with experience of people development
Proficiency in English
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 him/her to thrive in a fast-paced, dynamic,
Results-driven environment.
Able to work effectively in a multi-cultural, highly matrixed organization
What’s in it for you
Competitive Benefit Package
Paid Company Holidays, Paid Vacation, Volunteer Time & More!
Learning & Development Opportunities
Employee Resource Groups
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Job Function Regulatory Affairs
Req ID: 2407021125W