Current jobs related to Senior Manager, Regulatory Affairs, CMC - High Wycombe, Buckinghamshire - TN United Kingdom

  • Manager Regulatory Affairs Submissions

    4 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom Lifelancer Full time

    Job Title: Manager Regulatory Affairs Submissions Job Location: High Wycombe UK Job Location Type: Hybrid Job Contract Type: Fulltime Job Seniority Level: Description: At Johnson & Johnson we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured where...

  • Regulatory Affairs Manager, UK&I

    2 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom Pladis Global Full time

    Want to help us bring happiness to the world? Want to join an ambitious and fast growing global biscuits and confectionery business investing heavily in iconic global brands, infrastructure and people? Then this is the place for you.As proud bakers and chocolatiers and custodians of iconic global brands, we don't compromise on the quality of ingredients in...

  • Regulatory Affairs Manager

    2 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom Carbery Food Ingredients Ltd Full time

    Reporting into the Head of Technical and as the manager of the Compliance team, the key purpose of this role is to ensure the compliance of Synergy products to both legal and customer expectations, and the provision of timely and accurate data to customers/3rd party organisations to support this.This will be achieved by:Ensuring compliance (of products,...

  • Senior Manager Commercial Quality UK

    3 hours ago

    High Wycombe, Buckinghamshire, United Kingdom This is an IT support group Full time

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...

  • Regulatory Compliance Analyst

    3 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom pladis Full time

    Want to help us bring happiness to the world? Want to join an ambitious and fast-growing global biscuits and confectionery business investing heavily in iconic global brands, infrastructure, and people? Then this is the place for you.As proud bakers and chocolatiers and custodians of iconic global brands, we don't compromise on the quality of ingredients in...

  • Regulatory Compliance Analyst

    2 days ago

    High Wycombe, Buckinghamshire, United Kingdom pladis Full time

    Want to help us bring happiness to the world? Want to join an ambitious and fast-growing global biscuits and confectionery business investing heavily in iconic global brands, infrastructure, and people? Then this is the place for you.As proud bakers and chocolatiers and custodians of iconic global brands, we don't compromise on the quality of ingredients in...

  • Manager Oncology Regulatory Medical Writing

    4 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom Lifelancer Full time

    Job Title: Manager Oncology Regulatory Medical Writing Job Location: High Wycombe UK Job Location Type: Hybrid Job Contract Type: Fulltime Job Seniority Level: Description:Manager Oncology Regulatory Medical Writing (1 of 3)At Johnson & Johnson Innovative Medicine what matters most is helping people live full and healthy lives. We focus on treating...

  • Senior Safety Engineer

    3 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom Copello Global Full time

    Senior Safety Engineer Buckinghamshire. £60,000 - £70,000Copello are pleased to be partnered with a major defence and aerospace organisation based nearby to High Wycombe, recruiting for a Senior Safety Engineer to join the team on a permanent basis.Joining an established and key business unit (airworthiness & safety), the Safety Engineer will be...

  • Senior Commercial Manager

    2 days ago

    High Wycombe, Buckinghamshire, United Kingdom RBU Sales UK Ltd ta iRecruit UK Full time

    Senior Commercial Manager - DBS REQUIREDLocation: HP11 2TTContract Length: 3 monthsWorking Hours: 40hrs per week (Start time 7:30)The Senior Commercial Manager is responsible for overseeing and managing the commercial aspects of Facilities Management (FM) and Construction Works projects. This role requires expertise in contract administration, client and...

  • Senior Technical BPA Analyst

    3 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom ECR Global Full time

    DB Pensions Senior Technical Analyst (Bulk Purchase Annuities - BPA)Our client is an ambitious BPA business on an accelerated growth trajectory. They seek a talented Senior Technical Analyst, highly adept at Pensions Data (for BPA scheme onboarding), scheme rules and entitlement calculations. The role is at a pivotal stage of their growth and offers an...

  • Personal Tax Manager

    24 hours ago

    High Wycombe, Buckinghamshire, United Kingdom TN United Kingdom Full time

    TPF Recruitment is delighted to partner with a leading independent firm of Chartered Accountants in High Wycombe. We are seeking a dedicated Personal Tax Manager to join their esteemed team. This role offers the opportunity to work within a successful, growing tax team, providing a diverse range of personal tax services to individuals, directors, and...

  • Senior Commercial Manager

    3 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom Fawkes & Reece London Full time

    Senior Commercial Manager:About the role of Senior Commercial Manager:Long term freelance opportunity for a Senior Commercial Manager in High Wycombe.I am currently assisting a market leading brand in their search for a Senior Commercial Manager to join their team. Our client takes pride in the developments they deliver and have regenerated various schemes...

  • Senior Configuration Manager

    2 days ago

    High Wycombe, Buckinghamshire, United Kingdom Biffa Full time

    Biffa High Wycombe, England, United KingdomSenior Configuration Manager3 days ago Be among the first 25 applicantsA quick look at the roleThe Senior Software Configuration Manager will define the software configuration strategy, tools and policies, leading the configuration of Biffa's SaaS and legacy systems. The job holder is responsible for defining the...

  • Policy Research Officer

    3 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom CILEx Regulation Limited Full time

    Policy Research Officer Do you have experience in policy research and analysis, preferably within a regulatory environment? Do you want to be a part of the growing organisation where you can really make an impact and get exposure to working directly with senior stakeholders?If so, this could be a great opportunity for youAbout the organisation – CILEx...

  • Senior Commercial Manager

    2 days ago

    High Wycombe, Buckinghamshire, United Kingdom JobMatcha Full time

    Senior Commercial Manager required ASAPJobMatcha Recruitment now operates on civil, rail, and construction projects across the UK and prides ourselves on empowering the worker by using our award-winning technology to match workers to jobs.We offer to upskill our workers and to maintain our workforce from project to project.Job DetailsJobMatcha is recruiting...

  • Part Time Executive Officer

    2 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom Virtual Bridges, Inc. Part time

    Join to apply for the Part Time Executive Officer role at Virtual BridgesPart Time - Job Opportunity: Executive Officer - Ministry of DefenceLocation: Primarily Remote working however will be required to travel for induction purposes, the main office is located in High Wycombe.Pay: £14.71 per hour (weekly Pay)Hours: Part Time - 18hrs week (working pattern...

  • Account Manager

    2 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom Life Sciences Recruitment Full time

    About the Role:We are seeking an experienced and motivated Account Manager with a minimum of two years' experience in medical communications to join our dynamic team. In this role, you will be responsible for managing client accounts, ensuring the successful delivery of high-quality medical communication projects, and building strong client relationships....

  • QSHE Manager

    2 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom Alexander Steele Recruitment Full time

    QSHE ManagerAlexander Steele is working exclusively with a global food manufacturing business to recruit an experienced QSHE Manager in Buckinghamshire. This role will focus on setting and achieving the highest standards for safety, food safety and product quality within the food industry and will ensure compliance with all regulatory requirements across...

  • Senior Data Manager

    2 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom Hays Technology Full time

    Job Description Your New Organisation CSSC Sports and Leisure is dedicated to promoting well-being and leisure opportunities, along with an active lifestyle among its members. With a rich history and a commitment to providing a wide range of sports and leisure activities, CSSC fosters a vibrant community where members can enjoy and benefit from various...

  • Senior Data Manager

    2 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom Hays Specialist Recruitment Full time

    Your New OrganisationCSSC Sports and Leisure is dedicated to promoting well-being and leisure opportunities, along with an active lifestyle among its members. With a rich history and a commitment to providing a wide range of sports and leisure activities, CSSC fosters a vibrant community where members can enjoy and benefit from various recreational...

Senior Manager, Regulatory Affairs, CMC

1 week ago

High Wycombe, Buckinghamshire, United Kingdom TN United Kingdom Full time

Social network you want to login/join with:

Senior Manager, Regulatory Affairs, CMC, High Wycombe

Client: Kenvue

Location: High Wycombe, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Reference: 014e92ca66d4

Job Views: 9

Posted: 24.03.2025

Expiry Date: 08.05.2025

Job 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.

  1. 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.
  2. 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.
  3. Manages the global &/or regional regulatory deliverables for drugs, dietary supplements & medical devices as relevant, within their brand area & geographic responsibility.
  4. Develops strong partnerships with Regulatory Affairs Franchise, R&D, Franchise (Marketing) and local business representatives.
  5. Facilitates and cultivates external relationships, representing Kenvue with the relevant regulatory agencies and industry & professional associations as required.
  6. Represents the Regulatory Affairs CMC function as appropriate in Self Care Franchise, functional and business Leadership teams.

Key Responsibilities

Regulatory Strategy

  1. Provides strategic regulatory input and technical guidance on global and/or regional regulatory requirements to product development teams.
  2. Supports the business initiatives, by strengthening propositions, influence and acts as strategic advisor on brand/need state portfolio forums.
  3. 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.
  4. Participates in cross-functional project teams to define RA resources, development program requirements and risks.
  5. Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
  6. Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at regional level.

Regulatory Compliance

  1. Maintains awareness of current regulations and anticipate implications and opportunities because of changes to the relevant regulatory environments.
  2. Communicates changes to appropriate management and cross functional experts as appropriate.
  3. Ensure that all products comply with local regulatory and quality system requirements.
  4. Ensures quality and compliance in all actions.
  5. Participate in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs and working instructions.
  6. Ensures that the enterprise Regulatory systems are accurate and fully maintained.
  7. Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally.
  8. Identifies and/or implements global/regional process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives.
  9. Supports internal and external audits and inspections in collaboration with quality function.
  10. Supports crisis management / PR matters as related to regulatory affairs.

Regulatory Advocacy

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

Team Management

  1. Provides technical and leadership development & coaching to build high performing team
  2. Evaluates deliverables of self/direct reports against set timelines, acting where necessary to minimize delays and anticipate difficulties/risks.

Additional Responsibilities

  1. Partners with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility.
  2. Represents Regulatory Affairs on cross-functional product/project teams and provides regulatory advice.
  3. Manages work groups and provides direction.
  4. Provides day-to-day instructions and suggested training activities to direct reports.
  5. Applies organizational understanding and awareness in decision making.
  6. Uses effective communication and employs influencing skills to continue to grow key relationships with internal/external contacts.
  7. Builds and guides team and develops direct reports.
  8. Recruits high caliber professionals and contractors to strengthen the business talent.
  9. Represent the Senior Director/Director Regulatory Affairs (CMC) as delegate on request.

Primary Location

Europe/Middle East/Africa-United Kingdom-England-High Wycombe

Job Function

Regulatory Affairs

#J-18808-Ljbffr