Junior Regulatory Associate

Navitas Life Science • Bogota, NJ

307d

About The Position

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. The role involves 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. Additionally, the candidate will 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. The candidate will 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. The role also includes providing adequate support, including responding to deficiency letters, to both global and other regional regulatory client teams for securing timely approval of regulatory submissions. Furthermore, the candidate will provide regulatory support to the team, participate, and provide regulatory advice in technical review, identify and assess regulatory risks associated with assigned projects, and communicate 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 to is essential. The candidate will also undertake and manage regulatory inspections and ensure compliance to clients submission standards, policies, and procedures.

Requirements

• 2 - 5 years' experience in a regulated life sciences environment.
• Significant hands-on registration experience in Regulatory Affairs (Human Medicinal Products).
• Proven ability to understand regulatory implications of product strategy regarding product label and associated impacts.
• Ability to interpret and apply regional/local regulatory guidance for CMC and safety related filing.
• Demonstrate ability to develop strong working relationships across multiple cultures and locations.
• Knowledge of global/regional regulatory guidelines and requirements.
• Proven strength in logical, analytical, and writing ability.

Responsibilities

• Review and finalize Global Regulatory Strategy Documents, CTD sections for IND, CTA, BLA, NDA, and ANDA submissions.
• Coordinate with cross functional teams, site, and global Regulatory Affairs teams for authoring, review, and finalization of dossiers.
• 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.
• Collaborate with global and regional regulatory client teams to author quality regulatory submissions.
• Review Health Authority queries and coordinate global strategy for response.
• Provide support in responding to deficiency letters for timely approval of regulatory submissions.
• Provide regulatory support and advice in technical review.
• Identify and assess regulatory risks associated with assigned projects and communicate to the team.
• Drive resolution of issues and communicate issues, impact, and outcomes to global regulatory management and core team.
• Keep up to date with international legislation, guidelines, and customer practices.
• Undertake and manage regulatory inspections.
• Ensure compliance to clients submission standards, policies, and procedures.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Professional, Scientific, and Technical Services
• Number of Employees: 501-1,000 employees