Lead Manager, CMC Regulatory Affairs

1 week ago

Hong Kong, Central and Western District, Hong Kong SAR China Gilead Sciences Singapore Pte. Ltd. Full time

Position Overview

Gilead Sciences is a pioneering biopharmaceutical organization dedicated to the discovery, development, and commercialization of transformative therapies for patients facing serious health challenges. Our mission is to enhance the quality of life for individuals suffering from critical illnesses globally. Gilead's focus areas encompass liver viral infections, inflammatory disorders, and oncology.

The CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs International Affiliate Team is on the lookout for a dynamic, inquisitive, and culturally adept Regulatory professional to join our team in a full-time capacity. This role will be based in Singapore or Hong Kong and will report directly to the CMC Regulatory Affairs International Affiliate Team Leader, with a primary focus on CMC activities in Australia and New Zealand.

Role Summary

As a Senior Manager in CMC Regulatory Affairs, you will be an integral part of the Global CMC RA organization, acting as the CMC RA Affiliate for designated products and regions. Your role will involve collaborating with global teams to design and implement CMC RA strategies that align with the objectives of Pharmaceutical Development and Manufacturing (PDM) and the business goals of the Affiliate.

Key Responsibilities

In this capacity, you will:

  • Ensure that the CMC components of regulatory submissions comply with ICH and regional/local regulations.
  • Execute CMC regulatory submissions, including clinical trial applications, amendments, marketing authorizations, and post-approval variations.
  • Engage in timely discussions and negotiations with health authorities regarding CMC inquiries, ensuring consistent responses in collaboration with local and international colleagues.
  • Manage document filing and retrieval in accordance with departmental SOPs.
  • Oversee workflows related to document tracking, indexing, and information dissemination to key stakeholders.
  • Conduct CMC change control assessments in line with local regulations and best practices.
  • Collaborate with cross-functional teams to define regulatory strategies and filing plans, anticipating regulatory inquiries.
  • Provide local expertise in CMC regulatory requirements to contribute to global filing strategies.
  • Participate in process improvements impacting the CMC Regulatory Affairs function.
  • Stay informed on CMC registration requirements and best practices, assessing their impact on current and future submissions.
  • Facilitate knowledge sharing using designated management tools.
  • Guide stakeholders on the implications of regional circumstances, including cultural and economic factors.
  • Ensure compliance and consistency for assigned products with regulatory requirements.
  • Communicate CMC changes affecting labeling to relevant stakeholders.
  • Participate in updates related to legislative changes.
  • Mentor and support the training of team members as needed.
  • May serve as a Product Leader or International representative on project teams.

Skills and Competencies

  • Proven ability to develop and implement effective regulatory strategies.
  • Strong coordination skills for preparing various CMC regulatory documents.
  • Strategic prioritization and risk management capabilities.
  • Excellent organizational skills to manage multiple products and markets simultaneously.
  • Exceptional verbal and written communication skills, with a focus on clarity and cultural sensitivity.
  • Effective negotiation and influencing skills.
  • Ability to think critically and strategically to promote innovative solutions.
  • Willingness to take ownership and leverage empowerment.
  • Demonstrated networking and alliance-building skills.
  • High cultural awareness and appreciation for diversity.
  • Growth mindset with adaptability to change and resilience under pressure.
  • Ability to work independently with minimal guidance.

Knowledge and Qualifications

  • A scientific degree with relevant professional experience in small molecules CMC regulatory activities, preferably 8 years with a Bachelor of Science or 6 years with a Master of Science.
  • Proficiency in written and spoken English; knowledge of additional languages is a plus.
  • In-depth knowledge of ICH, EU, and Australian CMC regulatory requirements.
  • Experience with regulatory submissions in Australia/New Zealand is strongly preferred.
  • Familiarity with authoring CMC components for marketing authorization submissions.
  • Experience in representing CMC regulatory affairs on cross-functional teams.
  • Participation in Health Authority interactions is advantageous.
  • Experience with drug-device combination products is a plus.

Gilead Core Values

  • Integrity (always doing the right thing)
  • Teamwork (collaborating in good faith)
  • Excellence (working at a high level of commitment and capability)
  • Accountability (taking personal responsibility)
  • Inclusion (encouraging diversity)

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