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Director, Regulatory Affairs

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Director, Regulatory Affairs, North America Company: SANOFI

Location: Cambridge

Posted on: September 13, 2020

Job Description:

Director, Regulatory Affairs, North America From Research andDevelopment to Sales and Marketing, Sanofi offers a wide range ofpossibilities. Discover our open positions and become a healthjourney partner.

Do you have what it takes for a successful career withSanofi?

The role is primarily responsible to proactively developinnovative, robust US regulatory strategies and ensure theirefficient and effective execution for pipeline and lifecycle assetsin clinical development for assigned therapeutic area which adhereto US regulatory and company guidelines.In addition, the rolerepresents Sanofi to the US FDA for assigned projects and leads thestrategic development of documentation submitted to the US FDA andleads FDA meetings. Further, the role represents the NA GRAperspective as a member of project specific cross functional globalregulatory team (GRT) and be accountable to develop and maintain USaspects of regulatory strategy documents and for US regulatoryissues at internal governance meetings. In addition, the roleprospectively works with the NA labeling strategist and the GlobalRegulatory Team to develop US prescribing information. The roleworks with and participates on multi-disciplinary matrixed projectteams to successfully meet project deliverables while adhering toregulatory requirements for programs and products. The roleparticipates in the development and monitoring of the US regulatoryenvironment and updating of standards and processes related to drugand biologics US regulations. Lastly, the role may supervise,and/or coach mentor, junior staff supporting regulatory team.

Strategic & Technical Regulatory Affairs Expertise:

Strategic thinker

Solid knowledge and understanding of complex medical andscientific subject matter as well as evolving US regulatory policyand guidance

Strong strategic skills including the ability to make complexdecisions and willingness to defend difficult positions

Demonstrated experience with preparation of initial BLA, NDA, orMAA, INDs, Health Authority meeting briefing documents

Understanding of the development of drugs and/or innovativebiologics products. Experience in orphan drugs a plus

Develops collaborative relationships to facilitate theaccomplishment of work goals

Shows ability to use appropriate interpersonal styles andtechniques and can modify behavior to gain acceptance of ideas orplans

Excellent oral and written presentation skills

Direct interaction/negotiation experience with US FDA

Ability to work well within cross-functional globally orientedteams

Demonstrates excellent oral communication and writing skills

Other Personal Characteristics:

Excellent operational skills including planning, organizing andability to motivate and lead others

Ability to work in electronic document management system

Thorough understanding of the U.S. pharmaceutical marketplaceand familiarity with medical terminology

Ability to understand issues, problems, and opportunities bycomparing data from different sources to draw conclusions and thencan choose a course of action or develop the appropriatesolution

Ability build transversal networks to obtain cooperation withoutrelying on authority

High standards of integrity

Strong interpersonal skills

Dedicated and persuasive “can-do” attitude

Independently motivated, detail oriented and good problemsolving ability

Self-motivated; entrepreneurial spirit; excellent timemanagement skills

Organizational savvy; be able to work in a highly matrixstructure including sharing knowledge with relevantstakeholders

“Think out of the box” mindset

Requirements:

At least 10 years' experience in drug development

Solid working knowledge of drug development process and USregulatory requirements

Demonstrated experience developing and implementing regulatorystrategies for US INDs, BLA, and/or NDAs

Experience with drug development in the therapeutic area

Demonstrated experience successfully operating in a globalenvironment

Advanced scientific degree preferred. B.A./B.S. or higher degree(s) in the sciences, or health related field, minimum 8 yearsregulatory strategy experience

Regulatory Certification (RAC) (optional)

Sanofi Inc. and its U.S. affiliates are Equal Opportunity andAffirmative Action employers committed to a culturally diverseworkforce. All qualified applicants will receive consideration foremployment without regard to race; color; creed; religion; nationalorigin; age; ancestry; nationality; marital, domestic partnershipor civil union status; sex, gender, gender identity or expression;affectional or sexual orientation; disability; veteran or militarystatus or liability for military status; domestic violence victimstatus; atypical cellular or blood trait; genetic information(including the refusal to submit to genetic testing) or any othercharacteristic protected by law.

#GD-SA

#LI-SA

At Sanofi diversity and inclusion is foundational to how weoperate and embedded in our Core Values. We recognize to truly tapinto the richness diversity brings we must lead with inclusion andhave a workplace where those differences can thrive and beleveraged to empower the lives of our colleagues, patients andcustomers. We respect and celebrate the diversity of our people,their backgrounds and experiences and provide equal opportunity forall.

Join our Talent Network and get Sanofi communications deliveredto your inbox. By submitting your information, you acknowledge thatyou have read our privacy policy and consent to receive emailcommunication from Sanofi.

Keywords: SANOFI, Cambridge , Director, Regulatory Affairs, North America, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Director, Regulatory Affairs, Other , Cambridge, Massachusetts

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