The Regulatory Affairs Manager - Consumers will be responsible for the management of a product or specified products within a Need State area for Cosmetics, OTC and/or Medical Devices
Principle responsibilities will be within Johnson & Johnson Consumer Health’s Skin & Essential Health business unit and will include being regulatory responsible for leading brands such as Aveeno, Aveeno Baby, JOHNSON’S Baby.
- Development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant Need State areas.
- Develop and support regulatory strategies in line with business plan.
- Partner with brand and cross functional team to explore new and revised claims for advertising copy and pack that are within the framework of the product classification
- Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met.
- Sign off packaging material, leaflets, and advertising/promotional material to ensure regulatory compliance for submissions via appropriate document approval systems
- Provide local Regulatory support for Crisis Management / PR matters
Fulfil Department compliance obligations that include:
- Processes, SOPs and working instructions are adherence and ownership of processes for continuous improvement
- Update relevant local and global databases to track current product information and facilitate product notification under the Cosmetics Regulation.
- Lead and support audits and inspections as they relate to Cosmetics
- Provide regulatory advice and perform due diligence for product acquisitions and agreements with third parties.
- Good Regulatory Practice and maintain strong awareness/knowledge of current regulatory requirements.
- Monitor changes in the regulatory environment and highlight any potential impact on J&J products with action plan where applicable
- Represent Regulatory Affairs on cross-functional product/project teams and provides regulatory advice and/or support (as appropriate) both internally and externally. Provide regulatory guidance to internal stakeholders, to allow them to make to key decisions on business-critical activities and project feasibility.
- Be curious about consumer insights and what opportunities they provide for claims, commercial or product innovation
- Interact with Regulatory Agency and seek advice when appropriate and respond to requests for further information and queries.
- Represent J&J and provide regulatory advice at e.g. joint Company/Trade Association initiatives, Regulatory Agency meetings as appropriate.
- Identify own training and development needs in discussion with Manager, to ensure a broadening skill and knowledge base and to maximise/optimise career development opportunities.
- Develop product and Need State area knowledge as needed, according to product responsibilities list.
- Life Sciences or Chemistry degree or equivalent.
- Sound working knowledge and experience of EU Cosmetics Regulation and associated UK requirements
- Good grasp of the regulatory framework and borderline between Medicines, Cosmetics and Medical Devices
- Good working knowledge of Advertising copy approval requirements in the UK for example. CAP, BCAP
- Experience of working relations with ClearCast and Advertising Standards Authority is desirable
- Excellent leadership and communication skills.
- Strong organisational skills, including the ability to prioritise workload.
- Detail-oriented, effective in written and oral communication
- Works independently to plan, conduct, and manage regulatory projects to meet department and company objectives
- Manage Need State areas, mentor Regulatory Executives and/or Contractors and provide day to day support. Monitors progress of applications of self/direct reports against set timelines.
- Responsible for identifying, implementing and managing key RA Departmental projects and/or strategies based on both short- and long-term RA Department objectives
J&J Consumer Services EMAE., Ltd (8675)