Global Regulatory Affairs Cmc Director

2 days ago

Singapore PRESTIGE BIOPHARMA LIMITED Full time

**_Job Summary
- **

The incumbent will:

- Provide expert advice to Senior Management and act as the global point of contact in the areas of CMC regulatory affairs.
- Act as global regulatory CMC lead for assigned development projects and define and execute Regulatory CMC Strategy from pre-clinical stage up to and including marketing authorisation
- Plan, prepare and conduct all CMC related aspects for interactions with national authorities and supra-national agencies (e.g., MPA, PEI, EMA, FDA, as well as WHO when relevant) in the scope of product development including market authorisation
- Set up, adjust and continuously optimize regulatory CMC processes and interfaces (internal and external)
- Monitor changes and evolution in the regulatory CMC landscape for therapeutics (Regulatory Intelligence); analyse the impact of drug changing regulations for Prestige´s products; and collect, evaluate, and disseminate relevant regulatory updates on competitors' developments

**_Main Tasks _**
- Develop global product regulatory strategies to optimize time to approval by Health Authorities (e.g FDA, EMA etc)
- Review CMC submissions and responses to Health Authorities in line with agreed global regulatory strategy and timelines
- Represent Prestige RA CMC in Health Authority meetings and lead preparation activities for meetings with Health Authorities on CMC related matters
- Interact directly with international Health Authorities, as required participate in and/or facilitate agency meetings.
- Develop and maintain constructive relations with key internal and external colleagues, e.g. cross functional colleagues within Prestige, with Alliance Partners, vendors and Health Authority representatives.
- Lead cross-functional teams responsible for the preparation of submissions and responses to Health Authority CMC questions at any phase of product development
- Ensure effective communication of CMC regulatory strategy, risks, and overall plans to leadership and cross-functional teams
- Accountable for the coordination and overall global approval of regulatory assessments for CMC changes
- Conduct coaching & training of staff pertaining to CMC and regulatory conformance
- Lead team members that define CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement
- Represent the Company with local and global regulatory authorities, vendors and corporate partners

**_Requirements _**
- PhD in biological science, chemistry or related discipline
- Minimum of 10 years relevant experience in Global Regulatory Affairs CMC during clinical, registration and/or post-marketing for Biologics and Vaccines
- Knowledge of CMC drug development (Drug Substance and Drug Product) and knowledge of multidisciplinary functions involved in drug development and manufacturing
- Demonstrated inclusive leadership, strategic thinking and change management to achieve business goals
- Proven ability to manage projects and multi-disciplinary teams across global locations and time zones
- Good combination of strategic and operational skills; ability to make flexible, but thorough decisions in a highly dynamic environment
- Excellent communication skills in English

  • Regulatory Affairs Manager

    3 hours ago

    Singapore KYOWA KIRIN ASIA PACIFIC PTE. LTD. Full time

    The Regulatory Affairs (RA) CMC Manager for APAC independently manages all regulatory CMC aspects of assigned Kyowa Kirin projects / products. This includes Biologics, Small Molecules, and Drug/Device combinations. Has sound understanding and experience in navigating Asia Pacific (APAC) regulatory environment as well as managing interactions with APAC...

  • Manager/Sr Manager, Regulatory Affairs CMC

    2 weeks ago

    Singapore Gilead Sciences, Inc. Full time

    Manager/Sr Manager, Regulatory Affairs CMC Job Description At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue...

  • Manager/Sr Manager, Regulatory Affairs CMC

    1 week ago

    Singapore Gilead Sciences, Inc. Full time

    Manager/Sr Manager, Regulatory Affairs CMC Job Description At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to...

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore Johnson & Johnson Full time

    Johnson & Johnson is currently seeking a Regulatory Affairs Specialist to join our Regulatory Affairs team located in Singapore. : The Regulatory Affairs Specialist is a member of the Local Operating Company (LOC) Regulatory Affairs team and is responsible for preparation of life cycle management submissions to the Health Authority. Globally dispatched life...

  • Director Regulatory Affairs

    3 days ago

    Singapore Planet Pharma Full time

    Director of Regulatory Affairs We’re partnering with a leading global clinical research organization (CRO) seeking an experienced Director of Regulatory Affairs to lead regional regulatory strategy and execution across APAC. This position offers the opportunity to represent the company’s regulatory strategy meetings, and Health Authority interactions –...

  • Director Regulatory Affairs

    18 hours ago

    Singapore Planet Pharma Full time

    Director of Regulatory Affairs We're partnering with a leading global clinical research organization (CRO) seeking an experienced Director of Regulatory Affairs to lead regional regulatory strategy and execution across APAC. This position offers the opportunity to represent the company's regulatory strategy meetings, and Health Authority interactions – a...

  • Regulatory Affairs Director, Apac

    3 hours ago

    Singapore Bayer Full time

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...

  • Director, Regulatory Affairs

    18 hours ago

    Singapore Ethos BeathChapman Full time

    Join to apply for the Director, Regulatory Affairs (APAC) role at Ethos BeathChapman 3 days ago Be among the first 25 applicants Global Contract Research Organisation (CRO)Location: Singapore (Flexible)We are an expanding global Contract Research Organisation (CRO) dedicated to advancing clinical research and improving patient outcomes worldwide. As part of...

  • Director, Regulatory Affairs

    19 hours ago

    Singapore Ethos BeathChapman Full time

    Join to apply for the Director, Regulatory Affairs (APAC) role at Ethos BeathChapman 3 days ago Be among the first 25 applicants Global Contract Research Organisation (CRO) Location: Singapore (Flexible) We are an expanding global Contract Research Organisation (CRO) dedicated to advancing clinical research and improving patient outcomes worldwide. As part...

  • Director, Regulatory Affairs

    3 days ago

    Singapore BEATHCHAPMAN (PTE. LTD.) Full time

    Global Contract Research Organisation (CRO) Location: Singapore (Flexible) We are an expanding global Contract Research Organisation (CRO) dedicated to advancing clinical research and improving patient outcomes worldwide. As part of our continued growth across the Asia‑Pacific region, we are seeking an experienced and visionary Director, Regulatory Affairs...