Junior Regulatory Associate

Job Description

We are currently seeking a Junior Regulatory Associate. Within the role you will be responsible for:

  • The review and finalization of Global Regulatory Strategy Documents, CTD sections for IND, CTA, BLA, NDA, and ANDA submissions and ensure effective data presentation as per guidance
  • The effective co-ordination with cross functional teams, site, and Global RA teams for the authoring, review, and finalization of dossiers for pipeline products to ensure effective data presentation and quality
  • Preparing quality dossiers for pipeline molecules and supplements to support product launch
  • Monitoring and setting timelines for filling MA transfers, variations, license renewals, product amendments/supplements, and other product life cycle management activities including, but not limited to annual reports and safety report filing
  • Collaborating with the company’s global and other regional regulatory teams to author quality regulatory submissions for pipeline products
  • Reviewing health authority queries and co-ordinating a global strategy for response.
  • Providing adequate support, such as responding to deficiency letters, to company’s' global and other regional regulatory teams for securing the timely approval of regulatory submissions
  • Providing regulatory support to team, participating and providing regulatory advice for technical review
  • Identifying and assessing regulatory risks associated with assigned projects and ensuring timely communication to the team to quickly mitigate such risks
  • Driving issue resolution. Communicating issues, impact, and outcomes to global regulatory management and core team
  • Keeping up to date with international legislation, guidelines, and customer practices in all countries that the client is exporting its products
  • Undertaking and managing regulatory inspections
  • Remaining knowledgeable about current regulations and guidance, interpreting and implementing as appropriate in assigned projects
  • Ensuring compliance to clients submission standards, policies, and procedures

Desirable Skills and Experience

  • 2-3 years’ experience working in a regulated life sciences environment
  • Significant hands-on registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs (Human Medicinal Products); preferably from the perspective of CMC writing and authoring, review and approval of labelling documents
  • Proven ability to successfully understand regulatory implications of product strategy with regard to the produced label, assessment, and practical management of associated impacts
  • Demonstrated ability to interpret and apply regional/local regulatory guidance for CMC and safety related filing in the pre-approval and post approval (maintenance) stages
  • Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations
  • Knowledge of global/regional regulatory guidelines and requirements important
  • Proven strength in logical, analytical and writing ability essential

UK - Remote

Graduate/Post Graduate with a Life Sciences degree (preferably relating to Regulatory Affairs or Pharmacovigilance)

Project Manager

Regulatory Affairs

Full Time

19 Nov 2021