CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

Director, Regulatory Affairs

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 16, 2020

Job Description:

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. Director, Regulatory Affairs, North America

Company: SANOFI

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Director, Regulatory Affairs, North America From Research and Development to Sales and Marketing, Sanofi offers a wide range of possibilities. Discover our open positions and become a health journey partner.

Do you have what it takes for a successful career with Sanofi?

The role is primarily responsible to proactively develop innovative, robust US regulatory strategies and ensure their efficient and effective execution for pipeline and lifecycle assets in clinical development for assigned therapeutic area which adhere to US regulatory and company guidelines.In addition, the role represents Sanofi to the US FDA for assigned projects and leads the strategic development of documentation submitted to the US FDA and leads FDA meetings. Further, the role represents the NA GRA perspective as a member of project specific cross functional global regulatory team (GRT) and be accountable to develop and maintain US aspects of regulatory strategy documents and for US regulatory issues at internal governance meetings. In addition, the role prospectively works with the NA labeling strategist and the Global Regulatory Team to develop US prescribing information. The role works with and participates on multi-disciplinary matrixed project teams to successfully meet project

deliverables while adhering to regulatory requirements for programs and products. The role participates in the development and monitoring of the US regulatory environment and updating of standards and processes related to drug and 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 and scientific subject matter as well as evolving US regulatory policy and guidance

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

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

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

Develops collaborative relationships to facilitate the accomplishment of work goals

Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans

Excellent oral and written presentation skills

Direct interaction/negotiation experience with US FDA

Ability to work well within cross-functional globally oriented teams

Demonstrates excellent oral communication and writing skills

Other Personal Characteristics:

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

Ability to work in electronic document management system

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

Ability to understand issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution

Ability build transversal networks to obtain cooperation without relying on authority

High standards of integrity

Strong interpersonal skills

Dedicated and persuasive "can-do" attitude

Independently motivated, detail oriented and good problem solving ability

Self-motivated; entrepreneurial spirit; excellent time management skills

Organizational savvy; be able to work in a highly matrix structure including sharing knowledge with relevant stakeholders

"Think out of the box" mindset

Requirements:

At least 10 years' experience in drug development

Solid working knowledge of drug development process and US regulatory requirements

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

Experience with drug development in the therapeutic area

Demonstrated experience successfully operating in a global environment

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

Regulatory Certification (RAC) (optional)

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-SA

#LI-SA

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.

Join our Talent Network and get Sanofi communications delivered to your inbox. By submitting your information, you acknowledge that you have read our privacy policy and consent to receive email communication from Sanofi.

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for

in category

within

* Let Cambridge recruiters find you. Post your resume for free!

* Get Cambridge Other jobs via email.

* View more Cambridge Other jobs

[INS: :INS]

Other Other Jobs

Urgent requirement for Amazon Workforce Staffing Amazon Order Pickerpacker in Amazon Workforce Staff

Description: Amazon Workforce Staffing Amazon Order Pickerpacker - Amazon Workforce Staffing Warehouse Team Member Seasonal, Part-Time, Full-Time, Flexible Hours Shifts: Overnight, Sunrise, Day, Evening, WeekendLocation (more...)

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/13/2020

Marketing Director, CVS Media Exchange Program Lead

Description: Search by job title, category, location, or Military MOS code Job ID: 1184166BR Location: RI - Woonsocket Street Address: 1026 Park East Dr Category: Management Marketing Job Description Serve (more...)

Company: CVS Caremark Corporation

Location: Woonsocket

Posted on: 09/13/2020

Sr. Director, Caremark Strategy

Description: Search by job title, category, location, or Military MOS code Street Address: 1 CVS Drive Category: Job Description CVS Health is poised to radically improve the health care industry. Through our (more...)

Company: CVS Pharmacy

Location: Woonsocket

Posted on: 09/13/2020

Salary in Cambridge, Massachusetts Area | More details for Cambridge, Massachusetts Jobs |Salary

Amazon Workforce Staffing Amazon Order Pickerpacker

Description: Amazon Workforce Staffing Amazon Order Pickerpacker - Amazon Workforce Staffing Warehouse Team Member Seasonal, Part-Time, Full-Time, Flexible Hours Shifts: Overnight, Sunrise, Day, Evening, WeekendLocation (more...)

Company: JobToMe - Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/13/2020

Principal Scientist

Description: Company: Pfizer Location: Cambridge Posted on: August 9, 2020 Job Description: ROLE SUMMARYThe Leukocyte-Tissue Interface LTI group islooking for a highly-motivated Principal Scientist to join (more...)

Company: Amazon

Location: Woonsocket

Posted on: 09/13/2020

Amazon Workforce Staffing Amazon Order Pickerpacker - Amazon Workforce Staffing

Description: Amazon Workforce Staffing Amazon Order Pickerpacker - Amazon Workforce Staffing Warehouse Team Member Seasonal, Part-Time, Full-Time, Flexible Hours Shifts: Overnight, Sunrise, Day, Evening, WeekendLocation (more...)

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/13/2020

Strategic Analytics Senior Advisor

Description: The Strategic Analytics Senior Advisor will be responsible for the following:. Collect and organize data/information from a variety of sources and multiple databases. Transform and clean big data to make (more...)

Company: CVS Health

Location: Woonsocket

Posted on: 09/13/2020

Urgent requirement for Amazon Workforce Staffing Amazon Order Pickerpacker in Woonsocket

Description: Amazon Workforce Staffing Amazon Order Pickerpacker - Amazon Workforce Staffing Warehouse Team Member Seasonal, Part-Time, Full-Time, Flexible Hours Shifts: Overnight, Sunrise, Day, Evening, WeekendLocation (more...)

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/13/2020

Amazon Workforce Staffing Amazon Order Pickerpacker in Woonsocket

Description: Amazon Workforce Staffing Amazon Order Pickerpacker - Amazon Workforce Staffing Warehouse Team Member Seasonal, Part-Time, Full-Time, Flexible Hours Shifts: Overnight, Sunrise, Day, Evening, WeekendLocation (more...)

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/13/2020

Sr Director, Workforce Strategy

Description: Search by job title, category, location, or Military MOS code Job Description CVS Health is seeking a leader to drive operational delivery transformations through global service delivery model solutions (more...)

Company: CVS Caremark Corporation

Location: Woonsocket

Posted on: 09/13/2020 Strategic thinker

Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving US regulatory policy and guidance

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

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

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

Develops collaborative relationships to facilitate the accomplishment of work goals

Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans

Excellent oral and written presentation skills

Direct interaction/negotiation experience with US FDA

Ability to work well within cross-functional globally oriented teams

Demonstrates excellent oral communication and writing skills

Other Personal Characteristics:

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

Ability to work in electronic document management system

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

Ability to understand issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution

Ability build transversal networks to obtain cooperation without relying on authority

High standards of integrity

Strong interpersonal skills

Dedicated and persuasive "can-do" attitude

Independently motivated, detail oriented and good problem solving ability

Self-motivated; entrepreneurial spirit; excellent time management skills

Organizational savvy; be able to work in a highly matrix structure including sharing knowledge with relevant stakeholders

"Think out of the box" mindset

Requirements:

At least 10 years' experience in drug development

Solid working knowledge of drug development process and US regulatory requirements

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

Experience with drug development in the therapeutic area

Demonstrated experience successfully operating in a global environment

Advanced scientific degree preferred. B.A./B.S. or higher degree (s) in the sciences, or health related field, minimum 8 years regulatory strategy experience, Description: Amazon Workforce Staffing Amazon Order Pickerpacker - Amazon Workforce Staffing Warehouse Team Member Seasonal, Part-Time, Full-Time, Flexible Hours Shifts: Overnight, Sunrise, Day, Evening, WeekendLocation (more...)

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Remote Licensed Life Insurance Independent Contractor
Description: Licensed Life Insurance Independent Contractor - Work from Home br br br br We got what you want, you got what we need br br br br Are you a Licensed Insurance Agent looking for a flexible (more...)
Company: LiveOps
Location: East Providence
Posted on: 09/25/2020

Sort Center - Part-Time Up to $18/hr
Description: Full-time Warehouse Team Member - 500 sign-on bonus Hourly pay rate Earn 15.75 - 18.75/hr, plus benefits and a 500 sign-on bonus. Limited-Time Opportunity Location: Taunton, MA Job opportunities vary (more...)
Company: Amazon Workforce Staffing
Location: East Providence
Posted on: 09/25/2020

Part - Time Warehouse Operator - $15.25 - $18.25/hr
Description: Full-time Warehouse Team Member - 500 sign-on bonus Hourly pay rate Earn 15.75 - 18.75/hr, plus benefits and a 500 sign-on bonus. Limited-Time Opportunity Location: Taunton, MA Job opportunities vary (more...)
Company: Amazon Workforce Staffing
Location: East Providence
Posted on: 09/25/2020


Insurance Representative - Attleboro, MA
Description: Quick Facts: 10 10 Insurance Sales New and existing Clients 10 Leadership Positions Available 10 Hours: Monday - Friday 8-5 10 Client and Customer facing role 10 Actively Interviewing (more...)
Company: Aflac Regional Office
Location: East Providence
Posted on: 09/25/2020

Associate, Claims & Fraud Operations
Description: Associate, Claims Fraud Operations - 2002718 Description As a member of Santander---s retail banking division you---ll help serve Santander---s retail and small business customers as part of one of (more...)
Company: Santander Holdings USA Inc
Location: East Providence
Posted on: 09/25/2020

Warehouse Team Member - Flexible Morning Hours
Description: Full-time Warehouse Team Member - 500 sign-on bonus Hourly pay rate Earn 15.75 - 18.75/hr, plus benefits and a 500 sign-on bonus. Limited-Time Opportunity Location: Taunton, MA Job opportunities vary (more...)
Company: Amazon Workforce Staffing
Location: East Providence
Posted on: 09/25/2020

Amazon Order Picker/Packer
Description: br br Warehouse Team Member Part-Time, Full-Time, Flexible Hours br br Shifts: br Overnight, Sunrise, Day, Evening, Weekend br br Location br Fall River, MA br Job opportunities vary (more...)
Company: Amazon Workforce Staffing
Location: East Providence
Posted on: 09/25/2020

Amazon Order Filler - Immediate Hire ( Fall River)
Description: Warehouse Team Member Seasonal, Part-Time, Full-Time, Flexible Hours Shifts: Overnight, Sunrise, Day, Evening, WeekendLocation Fall River, MAJob opportunities vary by location. We update postings
Company: Amazon Workforce Staffing
Location: East Providence
Posted on: 09/25/2020

Full-time Warehouse Worker - $500 sign-on bonus
Description: Full-time Warehouse Team Member - 500 sign-on bonus Hourly pay rate Earn 15.75 - 16.75/hr, plus benefits and a 500 sign-on bonus. Limited Time Opportunity Location: Taunton, MA Job opportunities vary (more...)
Company: Amazon Workforce Staffing
Location: East Providence
Posted on: 09/25/2020

Warehouse Handler (Full-Time) - With $500 Sign-on Bonus
Description: Full-time Warehouse Team Member - 500 sign-on bonus br br Hourly pay rate: br Earn 15.75 - 18.75/hr, plus benefits and a 500 sign-on bonus. br Limited-Time Opportunity br br Location: (more...)
Company: Amazon
Location: East Providence
Posted on: 09/25/2020

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Cambridge RSS job feeds