UK REGULATORY AFFAIRS - SENIORREGULATORY AFFAIRS EXECUTIVE NORTHERN CLUSTER
Location : High Wycombe, UK
Main Responsibility :
Management of a product or specified productswithin a therapy area for Cosmetics, OTC and/or Medical Devices
Responsible for a large number of productsacross the J&J portfolio range in the UK, Ireland and Malta.
Development of regulatory strategies,preparation of regulatory applications and support maintenance activitieswithin relevant therapy area
Support regulatory activities for Nationaland/or European procedures (Decentralised, Mutual Recognition) as appropriate.
Develop and support regulatory strategies(local and regional) in line with business plan.
Complete regulatory activities for a definednumber of products to ensure all regulatory obligations and business objectivesare met.
Prepares and compiles regulatory submissions(Marketing Authorisations, Reclassifications etc.), responses to RegulatoryAgency (RA) questions and other correspondence in accordance with EUregulations and guidelines.
Sign off of packaging material, leaflets,SmPCs and advertising material to ensure regulatory compliance for submissionsvia Zinc, COCOON, Starfish systems etc.
Ensure Marketing Authorisations are maintainedand renewed.
Inform the Regulatory Agency/Department ofHealth (as appropriate) of product discontinuations and licencecancellations.
Ensures compliance within the department byensuring
Global, EAME and local databases are fullymaintained.
Processes, SOPs and working instructions areadhered to.
Update relevant local and global databases(e.g Documentum, Aris, GLR, Connect etc.) to track current productinformation.
Provide regulatory advice and perform duediligence for product acquisitions and distributor agreements with thirdparties.
Good Regulatory Practice
Maintain awareness/knowledge of currentregulatory legislation.
Ensures regulatory best practice at alltimes.
Monitor changes in the regulatory environmentand highlight any potential impact on McNeil Products Ltd / J&J products.
Act as an ambassador for the RegulatoryAffairs department and continues to raise profile of team both internally andexternally.
Represent Regulatory Affairs oncross-functional product/project teams and provides regulatory advice (asappropriate).
Interact with Regulatory Agency
Seekadvice when appropriate.
Respond to requests for further informationand queries.
Resolve any regulatory matters and expediteapproval of pending applications.
Provide regulatory guidance to internalstakeholders, to allow them make key decisions on business critical activitiesand project feasibility.
Represent J&J and provide regulatoryadvice at e.g. joint Company/Trade Association initiatives, Regulatory Agencymeetings etc (as appropriate).
Identify own training and development needs indiscussion with Manager, to ensure a broadening skill and knowledge base and tomaximise/optimise career development and opportunities.
Developproduct and therapeutic area knowledge as needed, according to productresponsibilities list.
Skills, Knowledge, Qualifications and Experience :
Life sciences or chemistry graduate to honourslevel or equivalent.
Works independently to plan, conduct, andmanage regulatory submissions and multiple projects to meet department andcompany objectives.
Work with minimal supervision to determine anddevelop approaches to solutions with technical guidance on a variety ofproblems of moderate scope and complexity.
May mentor Regulatory Executives and provideday to day support.
Project management, understanding ofregulatory environment, interaction with the Regulatory Authorities, commercial/ strategic awareness, implement regulatory strategy, managing and maintainingMarketing Authorisations.
Johnson & Johnson is an Affirmative Actionand Equal Opportunity Employer. All qualified applicants will receiveconsideration for employment without regard to race, color, religion, sex,sexual orientation, gender identity, age, national origin, or protected veteranstatus and will not be discriminated against on the basis of disability.
High Wycombe, England, Buckinghamshire, HP11, United Kingdom