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MSAT Regulatory Liaison, Director

Westborough, Massachusetts

Sanofi, a global healthcare leader, discovers, develops, and distributes therapeutic solutions focused on patients' needs. With 12 locations in Massachusetts, many located within close proximity to Boston, you'll have easy access to public transportation, popular restaurants, some of the best education, and most of all the history.

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Responsibilities

MSAT Regulatory Liaison, Director                                 

(Westborough, MA)  The Manufacturing Science and Technology (MSAT) organization is a network-focused function which provides strategic direction and technical and operational support to ensure that site and network goals and objectives are achieved.  MSAT’s primary functions are to lead technology transfers, implement control strategies, provide technical process support, and drive process lifecycle management for biologics drug substance operations for commercial products and product-related programs within the Sanofi Specialty Care Operations (SCO) perimeter.

In collaboration with Global CMC Biologics, responsible for driving the SCO Biologics regulatory and technical agenda and business interests while ensuring that the technical aspects and approaches related to the development of CMC submissions are maintained and applied consistently. The MSAT Regulatory Liaison will be responsible for establishing and ensuring consistency and alignment of scientific and technical content across regulatory submissions, including consistency of company positions/rationales related to product specifications, comparability, manufacturing and analytical control strategies, QbD approaches, etc.; and responses to regulatory agency queries. 

Responsible for proactively and actively representing and influencing scientifically sound product positions with US and Ex-US regulatory authorities as a technical expert.  A strong emphasis for this role is to coach technical colleagues who are serving as team leads/members on appropriate regulatory strategies, approaches and submission content.  Another key aspect of this role is to author regulatory submissions/responses, or review and critique the work product of others, to ensure scientifically sound positions/rationales are provided when interfacing with regulatory authorities. 

KEY RESPONSIBILITIES:

*Responsible for delivering robust regulatory strategies and approaches to ensure fast and right-first-time approval in global markets

*Leads transversal projects within MSAT where regulatory stances and activities are discussed across products to ensure alignment and consistent decision-making; presents and defends project and product regulatory strategies to key stakeholders and governance committees

*Authors submissions, briefing documents, regulatory responses, etc. to meet global regulatory requirements by leveraging acquired technical expertise and biotechnology industry experience

*Drives organizational/network learning by bringing a cross-product view to regulatory rationales; applies a holistic view to regulatory rationales vs product/site-centric approaches

Involved with interactions and negotiations with regulatory authorities and acts as the MSAT technical expert in articulating and negotiating for Sanofi’s proposals/positions, when needed

*Develops and provides technical approaches to the leader of major technology transfers and/or product team leads

*Maintains solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policies and guidelines; drives to adopt industry best practices

LEADERSHIP QUALIFICATIONS:

*Results oriented – sets ambitious tangible objectives and takes personal responsibility for achieving goals; excellent coordination skills including planning, organizing and ability to motivate and lead others

Collaborative – actively shares information and seeks input from outside direct team in support of technical challenges; develops strong cross functional/network relationships and partnerships with development, regulatory, commercial organizations, etc. to achieve desired outcomes

*Decisive – makes decisions even if outcomes are difficult; accepts accountability for results and makes choices using sound judgment; ability to make sound decisions with incomplete information

*Strategic – demonstrates an understanding of key trends that impact our business and drives that understanding into clear action plans; ability to identify risks and manage risks through mitigation and communication; strong technical networker and ability to work in a matrix environment; strong strategic skills including the ability to make complex decisions and wiliness to defend difficult positions

*Leadership – ability to lead, closely collaborate and build cross-functional teams; sets clear priorities and empowers/drives the team to meet challenges and take action

Continuous improvement – drives a continuous improvement mindset/culture; actively works to ensure best practices are developed/employed

*Develop people – takes responsibility for developing people; provides/seeks feedback on a regular basis

BASIC QUALIFICATIONS:

*Ph.D. 10+ years’ experience or MS 12+ years’ or BS 15+ years’ in a scientific or engineering discipline

*Expert problem solver and ability to think and work creatively

*Experience with biopharmaceutical process development and/or production operations (for example, mammalian cell culture, purification, and analytical characterization experience specific to biologics)

*Understands the importance/relevance of various regulatory and Boards of Health stances and requirements

PREFFERED QUALIFICATIONS:

*Prior Regulatory Affairs experience

*Hands on experience and in-depth scientific knowledge of biotech products whether in process development, product development, scale-up, or operations

*Excellent and effective verbal and written communication skills; strong technical writer

*Ability to collaborate and influence at all levels across the network with equal effectiveness (internal and external)

*Excellent interpersonal skills and team-player

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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