Junior Regulatory Associate

Job Description

We are looking for a Junior Regulatory Associate to join our expanding team. The successful candidate will:

  • Be responsible for the review and finalization of Global Regulatory Strategy Documents, CTD sections for IND, CTA, BLA, NDA, and ANDA submissions to ensure effective data presentation as per guidance
  • Be responsible for effective co-ordination with cross functional teams, site, and global Regulatory Affairs teams for the authoring, review, and finalization of dossiers for the pipeline products to ensure effective data presentation and quality
  • Prepare quality dossiers for pipeline molecules and supplements to support product launch.
  • Monitor and set timelines for filing MA transfers, variations, license renewals, product amendments/supplements, and other product life cycle management activities including annual reports and safety report filing, etc.
  • Collaborate with both global and other regional regulatory client teams to author quality regulatory submissions for pipeline products
  • Review Health Authority queries and co-ordinate global strategy for response
  • Provide adequate support, including responding to deficiency letters, to both global and other regional regulatory client teams for securing timely approval of regulatory submissions
  • Provide regulatory support to team, participate, and provide regulatory advice in technical review.
  • Identify and assess regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate any risks
  • Drive resolution of issues. Communicate issues, impact, and outcomes to global regulatory management and core team.
  • Keep up to date with international legislation, guidelines, and customer practices in all countries that the client is exporting its products to
  • Undertake and manage regulatory inspections
  • Be knowledgeable of current regulations and guidance, interpret and implement for assigned projects
  • Responsible for ensuring compliance to clients submission standards, policies, and procedures

Desirable Skills and Experience

  • 2 – 5 years’ experience in a regulated life sciences environment
  • Significant hands-on registration experience associated with the development, maintenance, and commercialization activities within Regulatory Affairs (Human Medicinal Products); preferably from the perspective of CMC writing and authoring, review and approval of labeling documents
  • Proven ability to successfully understand regulatory implications of product strategy with regard to the product label, assessment, and practical management of associated impacts
  • Demonstrate the ability to interpret and apply regional/local regulatory guidance for CMC and safety related filing in the pre-approval and post-approval (maintenance) stages
  • Demonstrate the 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

Bogota, Colombia

Bachelor’s Degree in Science or industry related

Junior

Regulatory Affairs

Full Time

22 Jul 2021