Jobs

    Regional Regulatory Affairs Manager - Singapore - INTEGRITY PARTNERS PTE. LTD.

    INTEGRITY PARTNERS PTE. LTD.
    INTEGRITY PARTNERS PTE. LTD. Singapore

    5 days ago

    Integrity Partners Pte. Ltd background
    Description
    Roles & Responsibilities

    You will be handling a portfolio of pharmaceutical products covering crucial therapeutic areas and managing regulatory activities across the ASEAN region.

    MAIN RESPONSIBILITIES

    1. Utilize exceptional interpersonal skills and influence to establish strong relationships with stakeholders and develop effective regulatory strategies for the long term.
    2. Manage the product lifecycle and regional submission pipelines in an efficient manner, leveraging technical and strategic expertise.
    3. Ensure that all regulatory processes are aligned with global standards and frameworks, while collaborating with internal and external stakeholders.
    4. Monitor regulatory intelligence both locally and internationally, anticipate potential issues, and develop strategies to mitigate them.
    5. Provide regulatory guidance to cross-functional teams and internal teams, as well as responses to health authorities.
    6. Conduct regulatory assessments of new product opportunities and advise on necessary regulatory requirements for bringing them to market.
    7. Manage regulatory projects and timelines, ensuring their timely completion.
    8. Maintain current knowledge of regulatory requirements and changes to regulations.
    9. Ensure compliance with all regulatory requirements, including the preparation and submission of regulatory filings.
    10. Represent the company in regulatory affairs matters and communicate with regulatory agencies on behalf of the company.
    11. Support quality assurance and pharmacovigilance activities as necessary.

    MUST HAVE

    • At least 5-8 years' experience in the pharmaceutical industry with regional experience working with innovative pharmaceutical pipelines in either chemical or biological entities
    • Proven successes in end-to-end new product registrations in the ASEAN region.
    • Experience in quality assurance and/or pharmacovigilance is an added advantage.
    • Relevant Bachelor's Degree (e.g. Pharmacy, Biomedical, Chemistry)

    DESIRABLE QUALITIES

    • Strong understanding of global and regional regulatory frameworks and processes
    • Self-start who is able to work independently and as part of a team
    • Proven successes in solving complex regulatory hurdles towards desirable outcomes.
    • Demonstrated qualities of critical thinking, project management and communication skills.

    INTERESTED APPLICANTS

    Please apply with your updated CV. Suitable candidates will be contacted for a confidential discussion regarding this exciting opportunity.

    We appreciate each application of interest for this position. As we carefully review and consider each application in our thorough selection process, we regret to inform that we will be reaching out only to shortlisted candidates for discussion.

    Not the right opportunity?

    We're always looking out for the best talents in the life science industry. If you are currently seeking exciting opportunities within the pharmaceuticals, medical devices, in-vitro diagnostics (IVD), or consumer health industry, do reach out for a confidential chat.

    Principal Consultant: Cheong Yee Yin | Registration Number: R | EA License Number: 17C8502

    Tell employers what skills you have

    Pharmaceutical Industry
    Regulatory Compliance
    Quality Assurance
    Pipelines
    Interpersonal Skills
    Regulatory Affairs
    Critical Thinking
    Chemistry
    Project Management
    Medical Devices
    Communication Skills
    Regulatory Requirements
    Life Sciences
    Therapeutic Areas
    Pharmacovigilance
    Able To Work Independently
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