Manager/Sr Manager, Regulatory Affairs CMC

The CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs International Affiliate Team is seeking a motivated, curious, flexible, and culturally aware regulatory professional to join our diverse, globally dispersed team. This full-time position is based in Gilead's Singapore office and is for the role of CMC Regulatory Affairs (Senior) Manager. The successful candidate will report to the CMC Regulatory Affairs International Affiliate Team Leader and will primarily be responsible for CMC activities in Australia and New Zealand.

Job overview/summary

CMC Regulatory Affairs (Senior) Manager while being a part of Global CMC RA organization serves as CMC RA Affiliate for assigned products and territories who through partnership with Global teams and full integration in RA Affiliate, design and execute CMC RA strategies that align PDM's (Pharmaceutical, Development, Manufacturing) CMC objectives with Affiliate's business goals.

Job responsibilities

In this role for your assigned markets/regions you will

• Ensure CMC part of the regulatory submissions meets ICH and regional/local regulatory requirements.

• Plan, author and submit CMC regulatory submissions including but not limited to clinical trial applications, amendments, supplements thereof, marketing authorizations, post-approval variations, periodic reports, and license renewals.

• Ensure and lead 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 in alignment with ICH and TGA 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 (i.e. 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 with 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 be assigned as a mentor or may support training of other colleagues on the team.

• May serve as International Product Lead on Global Project Teams.

Skills and Competencies

• Capable of developing and implementing optimal regulatory strategy and being a role model in the strategy execution.

• A proven ability to author and 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.

Knowledge and 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.
• Practical in-depth knowledge of ICH guidelines and EU and Australian CMC regulatory requirements, and an understanding of current global, regional, and local trends in CMC Regulatory Affairs.
• Experience with authoring of CMC components of marketing authorization and post approval submissions for small molecules (biologics experience would be an advantage).
• 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 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.