Senior Manager, Regulatory Affairs CMC

5 days ago

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

About the Role

Gilead Sciences Singapore Pte. Ltd. is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. With each new drug discovery and investigational candidate, we seek to improve the care of patients living with life-threatening diseases around the world.

Job Overview

The CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs International Affiliate Team is seeking a motivated, curious, flexible, and culturally aware experienced Regulatory professional to assume a full-time employment position in Gilead's office in Singapore or Hong Kong, China in the capacity of CMC Regulatory Affairs Senior Manager, reporting to the CMC Regulatory Affairs International Affiliate Team Leader, and primarily responsible for CMC activities in Australia and New Zealand.

Key Responsibilities

  • Ensure CMC part of the regulatory submissions meets ICH and regional/local regulatory requirements.
  • Perform CMC regulatory submissions including clinical trial applications, amendments, supplements thereof, marketing authorizations, post-approval variations, periodic reports, and license renewals.
  • Ensure timely discussion, and negotiation as necessary, with local/international health authorities regarding responses to CMC questions and work with international/local colleagues to ensure consistency of responses (using ICH Guidelines as the foundation and local guidelines). Author and submit the responses to the health authorities with a sense of urgency.
  • Perform document filing and retrieval functions as directed, or with departmental SOPs and work instructions.
  • Perform workflows and procedures regarding document tracking, indexing, and retrieving, and disseminating information to key stakeholders.
  • Perform CMC change control assessments against local regulations, guidance, and best practices.
  • Frequently interact and collaborate with colleagues outside of CMC RA to define strategy and filing plans (including Regulatory Affairs, Quality Assurance, Manufacturing Sites, Supply Chain and Commercial), including anticipation of regulators questions and responses.
  • Contribute to global filing strategy by providing local/regional expertise in CMC regulatory requirements and filing mechanisms through proposing optimally innovative, risk-based approaches including identification of CMC risk areas and development of alternative courses of actions.
  • Contribute to regulatory strategy and filings outside of the assigned market(s).
  • Contribute to local/regional/global process improvements, which have an impact on the working of the CMC Regulatory Affairs function or other functional areas.
  • Perform regulatory intelligence by keeping abreast of CMC registration requirements and best practices, assessing impact on the current and future fillings and communicate to stakeholders on a timely basis.
  • Follow knowledge sharing practices using designated knowledge management tools and processes.
  • Understands and guides relevant stakeholders and project teams on potential or actual impact of regional/local circumstances including cultural, economic, and social factors.
  • Ensure regulatory conformance and consistency for assigned products in compliance with regulatory requirements and internal procedures.
  • Ensure CMC changes with impact on labeling are communicated to the relevant stakeholders responsible for preparation and maintenance of country specific labeling.
  • May participate or lead updating and preparing the department for minor changes in legislation.
  • May initiate and contribute to local process improvements and/or global process improvements with impact on the CMC Regulatory Affairs function or other departments.
  • May be assigned as a mentor or may support training of other colleagues on the team.
  • May serve as Product Leader or International representative on Project teams.

Requirements

  • Capable of developing and implementing optimal regulatory strategy and being a role model in the strategy execution.
  • A proven ability to co-ordinate preparation of a variety of CMC regulatory documents in collaboration with other functions.
  • Strategic prioritization and implementation of risk-based approaches that includes analyzing, prioritizing, and mitigating regulatory risks.
  • Excellent organizational skills and ability to work on and/or oversee several products/markets simultaneously and with tight timelines.
  • Excellent verbal and written communication skills focused on delivering the right message to the right audience with an ability to convey information effectively with respect and cultural understanding.
  • Effective negotiating and influencing skills based on active listening and aiming at win-win solutions.
  • Ability to think both critically in the short-term and strategically in the long term with the desired outcome of promoting solutions that address both present and future challenges.
  • Willingness to take ownership and maximize benefits of empowerment.
  • Demonstrated ability of purposeful networking and building alliances.
  • Excellent cultural awareness and appreciation. Ability to work efficiently with highly diversified individuals and groups of people.
  • Growth mindset that enables open and rapid adaptation to change and new information, or unexpected obstacles. Ability to deal effectively with pressure; and remain optimistic and persistent, even under adversity.
  • Ability to work independently or with minimal guidance.

Qualifications

  • A scientific degree with directly relevant professional experience, preferably in small molecules CMC regulatory activities (biologics experience would be an advantage), of at least 8 years with a Bachelor of Science or 6 years with a Master of Science.
  • Fluent in written and spoken English. Knowledge of Chinese would be an asset.
  • Practical in-depth knowledge of ICH and EU and Australian CMC regulatory requirements, and an understanding of current global, regional, and local trends in CMC Regulatory Affairs.
  • Proven experience with submission compilation and filing a variety of regulatory submissions including marketing authorization and technical variations of different complexity in EU and/or other countries with similar regulatory requirements to Australia/New Zealand. Direct experience with submissions in Australia/New Zealand is strongly preferred.
  • Experience with authoring of CMC components of marketing authorization and post approval submissions for small molecules products would be an advantage.
  • Experience representing CMC regulatory affairs on regulatory and cross functional teams.
  • Participation and contribution to Health Authority interactions. Managing Health Authority interactions and experience with TGA would be an advantage.
  • Drug-device combination product experience would be an advantage.

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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