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MSAT Regulatory Liaison-Westborough,MA

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

Sanofi Biologics

JOB TITLE:

MSAT Regulatory Liaison, Director  

JOB CODE:

DEPARTMENT:

Global Manufacturing Science and Technology

SALARY GRADE: L4-1

REPORTS TO:

Head, Process & Product Control Strategy

LOCATION:

Westborough

SHIFT:

1st

EFFECTIVE DATE:

October 2018

VERSION:

1.0

DEPARTMENT DESCRIPTION:

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.

POSITION OVERVIEW/KEY RESPONSIBILTIES:

Position Overview

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.  Develops long and short-term regulatory strategies within MSAT.  Manages regulatory aspects of product projects that MSAT is leading throughout the life-cycle of the products.  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.

Responsible for proactively and actively representing and influencing scientifically sound product positions with US and Ex-US regulatory authorities as a technical and subject matter expert.  A strong emphasis for this role is to coach other 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.  Assesses the accuracy and appropriateness of submissions to support successful right-first-time applications.

Responsible for designing and executing effective approaches that influence the external global regulatory community, including scientific and regulatory advocacy at key scientific meetings and face-to-face regulatory agency meetings with regulatory authorities to advocate for specific Sanofi products. 

This position will have responsibility for new or next generation products for which MSAT has oversight as assigned from the Sanofi Biologics Specialty Care Operations portfolio.

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/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
  • Maintains solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policies and guidelines
  • Strong strategic skills including the ability to make complex decisions and wiliness to defend difficult positions
  • Develops scientifically sound technical content and strategic content/approaches(industry leading best practices and/or innovative and novel approaches) for submissions
  • Provides expert technical/scientific advice and responses to regulatory agency queries
  • Develops and applies platform knowledge, whenever possible, to streamline and simplify submission content and format enabling quicker internal submission processes
  • Ensures preparation of consistent submissions and drives organizational/network learning by bringing a cross-product view to regulatory positioning/rationales; applies a holistic view to regulatory rationales vs product/site-centric approaches
  • Direct interactions and negotiations with regulatory authorities (e.g., FDA, EMA, Health Canada, etc.) and acts as the voice of the company in articulating and negotiating for Sanofi’s proposals/positions as MSAT technical expert
  • Understands the scientific/technical and regulatory rationales that drive projects and uses that information to build regulatory documents that are readily accepted by regulatory agencies
  • Develops and provides technical approaches to the leader of major technology transfers and/or product team leads
  • Stays current on industry practices and global regulatory/industry guidance documents; drives to adopt industry best practices at Sanofi
  • Ability to identify risks and manage risks through mitigation and communication
  • Excellent coordination skills including planning, organizing and ability to motivate and lead others

LEADERSHIP QUALIFICATIONS:

  • Results oriented – Sets ambitious tangible objectives, takes personal responsibility for achieving goals
  • Collaborative – actively shares information and seeks input from outside direct team. Develops strong cross functional/network relationships and partnerships with development, regulatory, commercial organizations, etc. to achieve desired outcomes
  • Decisive – Makes decisions when needed 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
  • Leadership – Sets clear priorities and empowers/drives the team to meet challenges and take action. Encourages collaboration with and beyond the team.
  • Continuous improvement – Drives a continuous improvement mindset/culture; actively works to ensure best practices are developed/employed
  • Develop people – Takes responsibility for developing people. Learns from experience and helps others to do likewise. Provides and seeks feedback on a regular basis.

BASIC QUALIFICATIONS:

  • Ph.D. 10+ years’ experience or MS 12+ years’ or BS 15+ years’ in a scientific 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 assay development and analytical characterization experience specific to biologics and/or monoclonal antibodies)
  • Understands the importance/relevance of various regulatory and Boards of Health stances/requirements

PREFFERED QUALIFICATIONS:

  • Prior regulatory 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
  • Ability to collaborate and influence at all levels across the network with equal effectiveness (internal and external)
  • Ability to set ambitious targets and successfully drive results
  • Ability to share and  apply knowledge in support of technical challenges
  • Strong technical networker and ability to work in a matrix environment
  • Excellent interpersonal skills and team-player
  • Ability to lead, closely collaborate and build cross-functional working groups / teams

SPECIAL WORKING CONDITIONS:

  • None

DISCLAIMER:

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.  Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities.  This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.

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.

#GD-SG

#LI-GZ

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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