Job Title: Regulatory Affairs Associate (UK, Ireland & Malta)
Location: Hampshire, UK
Employment Type: 12 Month Contract (inside IR35)
Rate: £14.68 and £19.57 per hour PAYE only
The purpose of the Regulatory Affairs Associate/Senior Associate role is to manage the operational and technical aspects of regulatory affairs for the UK and Ireland marketing affiliate and the Maltese marketing affiliate, including:
· Execute the Regulatory Plan/objectives to ensure the success of new product registrations, line extensions and new indications in alignment with the affiliate business plan, while maintaining compliance for all products with local regulations and quality system requirements
· Foster an environment of operational excellence and collaborate with cross functional teams to successfully achieve affiliate regulatory objectives
· Facilitate and cultivate relationships with the local regulatory agencies and trade associations
Primary Responsibilities:
· Implement the Regulatory Plan in alignment with affiliate business plans as well as with regulatory requirements.
· Ensure submission and approval of high quality regulatory applications within planned timeframes. Maintain or support maintenance of clear metrics for regulatory deliverables.
· Preparation and support of new applications to obtain marketing authorisations
· Voicing affiliate perspective and needs to global and regional regulatory contacts
· Ensuring timely responses to requests from support groups and/or regulatory authorities
· Maintaining marketing authorisations (timely submission of post-approval maintenance activities like renewals, variations and periodic reports)
· Maintain regulatory tools in alignment with defined compliance metrics
· Support affiliate launch teams anticipating potential regulatory constraints and delivering regulatory outcomes to support the affiliate launch plan
· Represent the regulatory affairs function as appropriate in brand teams and New Product Planning discussions
· Facilitate interactions with regulatory bodies on a regular basis
Labelling
· Perform the function of Primary, Delegate or Alternate Affiliate Labelling Responsible Person (ALRP), ensuring that Product Information complies with local regulatory requirements and that updated Product Information is submitted, approved and implemented within the designated internal and/or regulatory authority timeframes
· Follow global labelling procedures and document relevant exceptions in order to produce accurate and high quality Product Information which is in compliance with global core labelling
Regulatory Compliance
· Ensure that internal regulatory IT tools and trackers are up to date and accurate
· Ensure that all products comply with local regulations and quality system requirements whichever is more stringent
· Ensure that the regulatory archive is complete and up to date and ensure that all current licenses and labels are readily available
· Support internal audits / assessments / self-inspections / external inspections in collaboration with Medicines Quality Organisation and local Ethics and Compliance
Requirements:
· 12 month to 16 months of experience supporting the UK Affiliate.
· Experience supporting post approval activities.
· Experience submitting through National procedure.
For this role you will need to be based in the UK and be able to commute to Basingstoke 3x a week. Please note this role does not offer sponsorship.
For more details please reach out to [email protected]