Senior Manager, Regulatory Affairs CMC

vor 5 Monaten

Zug, Schweiz Gilead Sciences Switzerland Sarl Vollzeit

Description


 

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 Zug, Switzerland 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 Switzerland and Israel.

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

Prepare the CMC sections for all types of submissions in the product lifecycle, for a range of investigational and commercial products, including small molecules and biologics, in international markets. 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.

Skills and Competencies

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.

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 and German. Knowledge of Hebrew would be an asset. Practical in-depth knowledge of ICH and EU and/or Swiss 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 the region and/or in countries which closely follow EU requirements. Direct experience with CMC submissions in Switzerland is 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 Swissmedic would be an advantage. Drug-device combination product experience would be an advantage.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.


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