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 Didn't find what you're looking for? Search again! Other Other
Jobs Marketing Director - CVS Media Exchange Program Lead Description: Search by job title, category, or location Job ID:
1184166BR Location: RI - Woonsocket Street Address: 1026 Park East
Dr Category: Management Marketing Job Description Serve as the CMX
point (more...) Company: CVS Health Location: Woonsocket Posted on: 09/14/2020 Amazon Workforce Staffing Amazon Warehouse Handler Benefits Day
One in Woonsocket Description: Amazon Workforce Staffing Amazon Warehouse Handler
Benefits Day One - Amazon Workforce Staffing Warehouse Team Member
Seasonal, Part-Time, Full-Time, Flexible Hours Shifts: Overnight,
Sunrise, Day, (more...) Company: Amazon Workforce Staffing Location: Woonsocket Posted on: 09/14/2020 Amazon Workforce Staffing Warehouse Team Member in
Woonsocket Description: Amazon Workforce Staffing Warehouse Team Member -
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: 09/14/2020 Amazon Workforce Staffing is looking for Amazon Workforce
Staffing Warehouse Team Member in Woonsock Description: Amazon Workforce Staffing Warehouse Team Member -
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: 09/14/2020 Amazon Workforce Staffing Warehouse Team Member Your Boss Is
Going to Miss You Amazon Workforce Staf Description: Amazon Workforce Staffing Warehouse Team Member -
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: 09/14/2020 Amazon Workforce Staffing Order Pickerpacker Immediate Hire Fall
River in Woonsocket Description: Amazon Workforce Staffing Order Pickerpacker
Immediate Hire Fall River - Amazon Workforce Staffing Warehouse
Team Member Seasonal, Part-Time, Full-Time, Flexible Hours Shifts:
Overnight, Sunrise, Day, (more...) Company: Amazon Workforce Staffing Location: Woonsocket Posted on: 09/14/2020 Amazon Workforce Staffing Warehouse Team Member - Amazon
Workforce Staffing Description: Amazon Workforce Staffing Warehouse Team Member -
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: 09/14/2020 Director - Service Excellence Portfolio Strategy Description: The Director, Portfolio Strategy for Service
Excellence is a critical thought leader on the Enterprise
Modernization team, responsible for developing strategic and
operational initiatives across the Service (more...) Company: CVS Health Location: Woonsocket Posted on: 09/14/2020 Amazon Workforce Staffing is looking for Amazon Workforce
Staffing Amazon Warehouse Handler Benefit Description: Amazon Workforce Staffing Amazon Warehouse Handler
Benefits Day One - Amazon Workforce Staffing Warehouse Team Member
Seasonal, Part-Time, Full-Time, Flexible Hours Shifts: Overnight,
Sunrise, Day, (more...) Company: Amazon Workforce Staffing Location: Woonsocket Posted on: 09/14/2020 Time To Re Build with Amazon Workforce Staffing Amazon Warehouse
Handler Benefits Day One at Amazon Description: Amazon Workforce Staffing Amazon Warehouse Handler
Benefits Day One - Amazon Workforce Staffing Warehouse Team Member
Seasonal, Part-Time, Full-Time, Flexible Hours Shifts: Overnight,
Sunrise, Day, (more...) Company: Amazon Workforce Staffing Location: Woonsocket Posted on: 09/14/2020 Company or Job Title Location (City, State) Powered by Company
reviews , salary info, and interview questions for thousands of
jobs .
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!
Other Other JobsAmazon Online Order Shopper (Part-Time Regular) - Earn $15/hr or more Description: Schedule:--Part-Time Regular br br Salary br Earn 15.00/hr or more br br Amazon remains open as an essential service to serve our communities delivering critical supplies directly to the doorsteps (more...) Company: Amazon Location: Weymouth Posted on: 09/20/2020 Nursing Aides (CNA & HHA) Multiple Shifts Description: We are currently hiring Home Health Aides HHAs and Certified Nursing Assistants CNAs for various open positions including but not limited to: AM, PM AND NIGHT SHIFTS WEEKDAYS OR WEEKENDS OR BOTH (more...) Company: CareInHomes Location: East Providence Posted on: 09/20/2020 Nursing Aide / CNA (PT - FT Needed) Description: Are you a Certified Nursing Assistant CNA with the desire to grow your professional career while caring for and enriching the lives of your patients Then you've come to the right place We are seeking (more...) Company: CareInHomes Location: East Providence Posted on: 09/20/2020 Credentialed Tax Expert - CPA Description: Overview If you are a highly motivated individual with an active unrestricted credential CPA/EA/Practicing Attorney and excellent communication skills, we need you to help our customers complete their (more...) Company: Intuit Location: Concord Posted on: 09/20/2020 Veterans Preferred - Paid Apprenticeships and Paid Online Cyber Degrees Description: Military Veterans are Encouraged to Apply. Earn your degree while you work. Employers are hiring nationwide You don't have to choose between going back Company: Purdue University Location: Concord Posted on: 09/20/2020 Caregiver (Full-time and Part-time) Description: We are looking for caregivers, of all experience levels, to become a part of our caregiver network Dependable, compassionate, and upbeat caregivers who can provide companion care, personal care, and/ (more...) Company: CareInHomes Location: Concord Posted on: 09/20/2020 Amazon Shopper (Part Time) - Immediately Hiring Description: Schedule:Part-Time RegularSalaryEarn 15.00/hr or moreAmazon remains open as an essential service to serve our communities delivering critical supplies directly to the doorsteps of people who need them.Amazon (more...) Company: Amazon Location: Weymouth Posted on: 09/20/2020 CDL-A Refrigerated Truck Driver - Flexible Home Time! Description: CDL-A TRUCK DRIVER JOBS -REFRIGERATED FREIGHT Top Pay Flexible Home Time NEW Address-to-Address Mileage Pay More Accurately Reflects The Miles YOU Drive Join a growing fleet As a Roehl refrigerated (more...) Company: Roehl Transport Inc Location: Taunton Posted on: 09/20/2020 Customer Service/Sales Description: Customer Service/Sales 305583291 Concord, New Hampshire, US, 03301 Position Purpose: Customer Service/Sales associates provide fast, friendly service by actively seeking out customers to assess their (more...) Company: The Home Depot Location: Concord Posted on: 09/20/2020 Seasonal Part-Time Amazon Package Sorter With $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 OpportunityLocation: Taunton, MAJob opportunities vary (more...) Company: Amazon Workforce Staffing Location: East Providence Posted on: 09/20/2020 |
