Talent.com
Regional Regulatory Compliance Officer

Regional Regulatory Compliance Officer

Chemill Pharma Ltd.Republic Of India, IN
3 days ago
Job description

Purpose of the Role :

Chemill Pharma is seeking a seasoned and detail-oriented Regulatory Affairs Manager to lead and oversee all regulatory activities across ASEAN markets and Hong Kong, while providing regional support for other territories as needed. The ideal candidate will have strong experience in managing end-to-end product registrations, leading teams, coordinating with global manufacturers, and driving timely submissions and approvals.

This role requires a balance of strategic oversight and hands-on execution, ensuring compliance with regional regulatory frameworks while supporting Chemill’s business growth and product pipeline.

Key Responsibilities :

1. Dossier Review and Evaluation

  • Review and evaluate dossiers received from manufacturers in accordance with ASEAN, Hong Kong, and country-specific registration guidelines.
  • Ensure documentation completeness, accuracy, and adherence to local regulatory formats.
  • Proactively identify gaps and resolve potential issues prior to submission.

2. Compilation and Submission

  • Compile dossiers for final internal review & Submit dossiers directly to country-specific regulatory authorities' online platforms as per regulatory requirements.
  • Track submissions to ensure timely approval and lifecycle management.

    • 3. Communication and Coordination

  • Liaise with manufacturers for document revisions, data updates, and compliance alignment prior to submission.
  • Handle regulatory deficiencies and coordinate corrective actions efficiently.
  • Serve as the primary communication bridge between Chemill’s RA team, overseas partners, and local authorities.

    • 4. Query & Deficiency Management

  • Address CORP and NMPA (or respective ASEAN / HK agency) queries in a professional and timely manner.
  • Maintain clear documentation and ensure alignment of responses with company regulatory strategy.

    • 5. Labeling & Artwork Approval

  • Review and approve artworks to ensure compliance with Hong Kong’s bilingual (English / Chinese) labeling standards and other ASEAN-specific requirements.
  • Coordinate with internal design teams and manufacturers for final artwork approval before submission.

    • 6. Tender Support & Documentation

  • Prepare regulatory and compliance documents required for public tenders (Schedule B, USP / BP compliance).
  • Coordinate sample arrangements, re-labeling, and regulatory declarations in alignment with business timelines.

    • 7. Regional Team Leadership

  • Lead, mentor, and grow the Regulatory Affairs team in India , setting clear goals, KPIs, and development plans.
  • Oversee workload allocation, review performance, and drive accountability for results.
  • Foster a collaborative and high-performing regulatory function.

    • 8. Strategic Planning & Coordination

  • Develop regulatory roadmaps for new product registrations and renewals in ASEAN & HK.
  • Plan submission schedules, monitor progress, and ensure timely completion of all regulatory milestones.
  • Collaborate closely with BD, Supply Chain, Quality, and Marketing to support business objectives and product launches.

    • 9. Reporting & Compliance Tracking

  • Maintain up-to-date registration trackers and dashboards for ASEAN & HK submissions.
  • Generate monthly / quarterly reports for senior management.
  • Track renewals, variations, and post-approval changes proactively.

    • Qualifications & Experience

  • Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or a related discipline.
  • 5–8 years of regulatory affairs experience in the pharmaceutical industry, preferably with exposure to ASEAN and / or Hong Kong markets.
  • Proven experience leading teams and managing multi-country submissions.
  • Strong understanding of dossier compilation, electronic submission systems, and post-approval lifecycle management.
  • Excellent communication, coordination, and stakeholder management skills.
  • Proficiency in Microsoft Office, submission tracking tools, and eCTD software.
  • Detail-oriented with the ability to manage multiple priorities under tight timelines.
  • Willingness to travel when required.

    • Key deliverables :

  • On-time submission and approval of dossiers across ASEAN & HK.
  • Reduction in query resolution timelines and documentation gaps.
  • Successful onboarding, training, and retention of high-performing RA team members.
  • Regular process improvement and optimization of submission workflows.
    • Create a job alert for this search

    Compliance Officer • Republic Of India, IN

    Related jobs
    • Promoted
    Regulatory Compliance Manager

    Regulatory Compliance Manager

    vueverse.Republic Of India, IN
    Regulatory Submissions & Compliance.Author, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, ...Show moreLast updated: 1 day ago
    • Promoted
    Head of Regulatory Compliance

    Head of Regulatory Compliance

    CoinWNew Delhi, Republic Of India, IN
    The Principal Officer (PO) shall be an officer at the management level.To avoid conflict of interest, PO should be exclusively for responsibilities as cast under chapter IV of the PML Act and not b...Show moreLast updated: 3 days ago
    • Promoted
    Compliance Specialist

    Compliance Specialist

    PEARL TRANSPORT INCNagpur, IN
    We’re Hiring : Compliance & HR Specialist | Pearl Transport Inc.Pearl Transport Inc — a growing U.You will ensure company-wide FMCSA / DOT compliance while also supporting HR processes.You’ll work clo...Show moreLast updated: 2 days ago
    • Promoted
    Regulatory Affairs Officer

    Regulatory Affairs Officer

    HRipple SolutionsRepublic Of India, IN
    𝗣𝗼𝘀𝗶𝘁𝗶𝗼𝗻 : 𝗘𝘅𝗲𝗰𝘂𝘁𝗶𝘃𝗲 – 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲.𝗟𝗼𝗰𝗮𝘁𝗶𝗼𝗻 : 𝗞𝗮𝗻𝗱𝗶𝘃𝗮𝗹𝗶 (𝗛𝗲𝗮𝗱 𝗢𝗳𝗳𝗶𝗰𝗲). 𝗪𝗼𝗿𝗸𝗶𝗻𝗴 𝗗𝗮𝘆𝘀 : 𝟲 𝗱𝗮𝘆𝘀 (𝟮𝗻𝗱 𝗮𝗻𝗱 𝟰𝘁𝗵 𝗦𝗮𝘁𝘂𝗿𝗱𝗮𝘆 ...Show moreLast updated: 1 day ago
    • Promoted
    Senior Manager, Market & Regulatory Compliance - Derivatives

    Senior Manager, Market & Regulatory Compliance - Derivatives

    Olam AgriChennai, Republic Of India, IN
    Olam Agri ~ A differentiated, and market leading global agri-business focused on high-growth end consumption markets.Our food, feed, fibre, Agri-industrials & ag-services capabilities span 30+ coun...Show moreLast updated: 1 day ago
    • Promoted
    Compliance Specialist – Affordable Housing (LIHTC)

    Compliance Specialist – Affordable Housing (LIHTC)

    Castellan Real Estate PartnersNagpur, IN
    Compliance Specialist – Affordable Housing (LIHTC).Remote (Based in India, supporting California projects).Full-time | Must be available to work in Pacific Standard Time (PST) overlap hours.We are ...Show moreLast updated: 4 days ago
    • Promoted
    Senior Manager - Risk and Compliance

    Senior Manager - Risk and Compliance

    Good Business LabNagpur, IN
    We use rigorous academic research to prove that worker well-being programs have business impacts.We develop market-ready, scalable interventions that benefit both workers and businesses.Our goal is...Show moreLast updated: 3 days ago
    • Promoted
    Compliance Engineer - Sustainability Compliance (Remote)

    Compliance Engineer - Sustainability Compliance (Remote)

    CertivoNagpur, IN
    Remote
    Certivo turns regulatory evidence into market access.Our AI, CORA, automates supplier outreach, data extraction, and rule checks, then assembles market-ready packets mapped to every product × site ...Show moreLast updated: 14 days ago
    • Promoted
    Director of Regulatory Compliance

    Director of Regulatory Compliance

    Pay10 IndiaNew Delhi, Republic Of India, IN
    Regulatory Compliance (RBI & Other Authorities).Develop, implement, and maintain compliance programs in line with RBI regulations for PA, cross-border PA, and PPI license holders.Act as the primary...Show moreLast updated: 25 days ago
    • Promoted
    Compliance and Regulatory Affairs Lead

    Compliance and Regulatory Affairs Lead

    Tradeswift GroupJaipur, Republic Of India, IN
    We’re Hiring : Compliance (Manager / Asst.Broking & PMS operations watertight—translating regulations into clear processes and building a culture of “do it right, every time. SEBI / Exchanges), internal ...Show moreLast updated: 3 days ago
    • Promoted
    Regulatory Compliance Manager

    Regulatory Compliance Manager

    Evalueserve IndiaRepublic Of India, IN
    Elevate Your Impact Through Innovation and Learning.Evalueserve is a global leader in delivering innovative and sustainable solutions to a diverse range of clients, including over 30% of Fortune 50...Show moreLast updated: 25 days ago
    • Promoted
    Regulatory Compliance Lead

    Regulatory Compliance Lead

    CorenzaChennai, Republic Of India, IN
    This leading financial services company in India offers a wide range of retail financing products, including two-wheeler, used car, and consumer durable loans. With a nationwide presence, the compan...Show moreLast updated: 3 days ago
    • Promoted
    Regional Compliance Manager (APJ)

    Regional Compliance Manager (APJ)

    ConfidentialIndia
    Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology. At Leica Microsystems, one of 15+ operating companies, our work saves lives...Show moreLast updated: 7 days ago
    • Promoted
    Maritime Regulatory Manager - Based in UK

    Maritime Regulatory Manager - Based in UK

    Comaea ConsultingNagpur, IN
    Our client is a MNC n the maritime industry.To support the growth strategy and its expansion, our client is seeking an experienced. We are hiring on behalf of a leading global shipowner and shipping...Show moreLast updated: 4 days ago
    • Promoted
    Compliance and Contracts Specialist

    Compliance and Contracts Specialist

    EmeritusNagpur, IN
    The Compliance & Contract Management Services Department is looking for a Compliance and Contracts Associate to assess, analyze, draft, review, negotiate and finalize contracts, compliance, invoice...Show moreLast updated: 4 days ago
    • Promoted
    Regulatory Compliance Manager

    Regulatory Compliance Manager

    Systematix Shares & Stocks (I) Ltd.Republic Of India, IN
    Systematix Group is a leading diversified financial services firm offering a wide range of solutions, including.Investment Banking, Institutional Equities, Wealth Management, Retail Broking, and As...Show moreLast updated: 3 days ago
    • Promoted
    Manager, Regulatory Compliance

    Manager, Regulatory Compliance

    EYEGLOBAL SOLUTIONS PVT. LTD.Republic Of India, IN
    Regulatory affairs in a biotech / biopharma company with knowledge of drugs and cosmetics act, GMP, Schedule M and having worked extensively in CDSCO, Local FDA, DCGI, RCGM.Must have faced multiple a...Show moreLast updated: 3 days ago
    • Promoted
    Regulatory Affairs Specialist – (APAC & RoW)

    Regulatory Affairs Specialist – (APAC & RoW)

    vueverse.Nagpur, IN
    Regulatory Submissions & Compliance.Author, compile, and submit regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, ...Show moreLast updated: 2 days ago