Manager, Global Regulatory CMC EMEA
J&J Family of Companies, Terriers, Wycombe
Manager, Global Regulatory CMC EMEA
Salary not available. View on company website.
J&J Family of Companies, Terriers, Wycombe
- Full time
- U
- Onsite working
Posted today, 19 Oct | Get your application in now to be one of the first to apply.
Closing date: Closing date not specified
job Ref: ec64fab13f3a44ce9f972d1d7c6d73eb
Full Job Description
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.
- 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, 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 The Roles & Responsibilities include: 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 companys 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:
- 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. 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. Back up activities Represent the Senior Director/Director/Associate Director Regulatory Affairs (CMC) as delegate on request
- 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
Essential knowledge and skills: