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    Junior Regulatory Associate

    Navitas Life Sciences
    2-5 years
    Preffered by Company
    Remote - Europe
    10 Aug. 29, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    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

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