CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

Senior Manager,Global Regulatory Affairs CMC

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

Job Description:

Senior Manager, Global Regulatory Affairs CMC - Small Molecules Company: Takeda Pharmaceuticals International GmbH

Location: Cambridge

Posted on: September 14, 2020

Job Description:

Senior Manager, Global Regulatory Affairs CMC - Small MoleculesCompany: Takeda

Location: Cambridge

Posted on: May 14, 2020

Job Description:

By clicking the Apply button, I understand that myemploymentapplication process with Takeda will commence and that Iagree withTakedas Privacy Notice, Privacy Policy and Terms ofUse.JobDescriptionAre you looking for a patient-focused companythat willinspire you and support your career? If so, be empoweredto takecharge of your future at Takeda. Join us as a SeniorManager,Global Regulatory Affairs CMC - Small Molecules in ourCambridgeoffice.

Here, everyone matters and you will be a vital contributor toourinspiring, bold mission. As a Senior Manager working on theGlobalRegulatory Affairs CMC team, you will be empowered to developandlead the execution of regulatory CMC investigational,registrationand post-approval strategies for assigned products, anda typicalday will include:

OBJECTIVE:

Regulatory Affairs CMC member on Regulatory,PharmaceuticalDevelopment, and Commercial project teams throughoutclinicaldevelopment and commercial lifecycle.

Develops and applies a comprehensive understanding of globalRACMC regulations and guidelines to projects to enhanceprobabilityof regulatory success and regulatory compliance.

With moderate supervision, successfully communicatesandnegotiates with international Health Authorities asnecessary,directly and indirectly.

Develops constructive relationships with andproactivelycommunicates issues to key internal and externalcolleagues,including Alliance Partners..

ACCOUNTABILITIES:

With minimal supervision, plans, executes and managesregulatorysubmissions for assigned compounds in various phases ofclinicaldevelopment, global marketing applications, andpost-approval lifecycle activities.

As a RA CMC product leader or member, ensures and/orenhancesregulatory compliance with respect to filing requirementsforassigned compounds throughout development and the commerciallifecycle.

Independently defines CMC content (data anddocumentation)requirements for regulatory submissions and reviewsthis contentfor conformance with established requirement.

With moderate supervision, represents Takeda RA CMC inHealthAuthority meetings and leads or supports CMC preparationactivitiesfor meetings with Health Authorities on CMC relatedmatters.

Interacts directly with international Health Authorities,asrequired.

Ensures project team colleagues, line management, andkeystakeholders are apprised of developments that mayimpactregulatory success, exercising sound judgement andcommunicating ina professional and timely manner.

Fosters constructive working relationships when interactingwithinternal and/or external colleagues.

Evaluates change proposals for global regulatory impact.andplans global variations and amendments.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

BS/BA Degree in a Scientific Discipline, AdvancedDegreepreferred.

6+ years pharmaceutical Regulatory CMC experience,includingexperience as an RA CMC product lead, or equivalentindustryexperience. (e.g., Pharmaceutical Development,AnalyticalDevelopment, Production, Quality Assurance).

Understanding of scientific principles and regulatoryCMCrequirements relevant to global drug development andpost-marketsupport.

Proven ability to provide strategic regulatory guidance todrugdevelopment, registration, and post-market support teams.

Able to deal with issues of critical importance withminimalsupervision. Provides regulatory advice and makingreasoneddecisions on regulatory issues for which there may notbeclear/specific regulatory guidance.

Demonstrates emerging leadership, problem-solvingability,flexibility and values teamwork.

Exercises good judgement in elevating and communicating actualorpotential issues to line management.

Excellent written and oral communication skills required.

Active participation in Agency/Industrygroups/forumspreferred.

PHYSICAL DEMANDS:

Routine demands of an office based environment.

Manual dexterity required to operate office equipment(i.e.computers, phones, etc.).

Carrying, handling and reaching for objects.

Ability to sit or stand for long periods of timewhiletraveling.

TRAVEL REQUIREMENTS:

Willingness to travel to various meetings, includingovernighttrips.

Requires approximately up to 10-30% travel.

*expectation for travel may depend on the projects tobesupported

WHAT TAKEDA CAN OFFER YOU:

401(k) with company match and Annual RetirementContributionPlan

Company match of charitable contributions

Health & Wellness programs including onsite flu shots andhealthscreenings

Generous time off for vacation and the option topurchaseadditional vacation days

Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

#LI-LC1LocationsCambridge, MAWorkerTypeEmployeeWorkerSub-TypeRegularTime TypeFull time

Keywords: Takeda, Cambridge , Senior Manager, Global RegulatoryAffairs CMC - Small Molecules, Executive , Cambridge,Massachusetts

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

Senior Manager of Quality Engineering

Description: At Tamr we believe that clean, up-to-date data isthe linchpin of making informed decisions. The Tamr softwareplatform uses a human guided machine learning approach to producehigh-quality unified data (more...)

Company: Tamr

Posted on: 06/8/2020

Associate Director New Product Planning

Description: We're looking for a candidate to fill this positionin an exciting company. li Act as Commercial Leader in projectteams from preclinical throughout phase III, providing commercialinput and guidance (more...)

Company: Chiesi USA

Posted on: 06/8/2020

Project Manager*

Description: The Project Manager will be responsible for avariety of detailed project management, financial, andadministrative activities involved in overseeing a small to mediumfederated program or several major (more...)

Company: Odyssey Systems Consulting Group

Posted on: 06/8/2020

Sr./Medical Director - Hematology

Description: Apex Systems has an immediate and excitingopportunity for a Quality Assurance Engineer at a Fortune 500telecom services company If interested, please email an updatedresume to Professional Recruiter (more...)

Company: Apex Systems

Posted on: 06/8/2020

Manager of Application Development

Description: Manager of Application Development Our client, analternative asset management company, is looking to hire a Managerof Application Development. The manager of app development will berequired to step (more...)

Posted on: 06/8/2020

Territory Manager / Surgical Specialties - Boston, MA

Description: Job Description SummaryJob DescriptionLocation:This is a field based role covering Boston, MA br br DivisionDescription: br br The BD Interventional Surgery Division offers abroad range of (more...)

Company: BD

Posted on: 06/8/2020

Associate Account Manager

Description: Everbridge seeks an experienced, customer-focusedAssociate Account Manager - Customer Transitions within ourIntegration Management Office IMO to own the swift transition ofacquired/merged customers (more...)

Company: EverBridge

Location: Burlington

Posted on: 06/8/2020

IT Security & Networking Manager - Braintree, MA

Description: Hello, Our client, located in Braintree, MA islooking to hire a IT Security Networking Manager as a permanentfull-time employee. I have attached below a detailed jobdescription for your review. If (more...)

Company: Pivotal Solutions Inc

Location: Braintree

Posted on: 06/8/2020

Remote Sales Development Manager - IT/Engineering Staffing

Description: Remote Account Manager ndash ITEngineering StaffingDuration 2-4mths contract with the possibility of fulltime afterLocation Remote role servicing nationwide We are looking for anexperienced, driven (more...)

Company: IT Mantra

Location: Wellesley

Posted on: 06/8/2020

Director of Community Relations

Description: Job Description Think senior living sounds boring --Think again.--At The Commons in Lincoln, we impact lives through human connection.--We are thought leaders creating qualityexperiences--and inspiring (more...)

Location: Lincoln

Posted on: 06/8/2020

Company or Job Title Location (City, State) Powered by Companyreviews , salary info, and interview questions for thousands ofjobs .

Keywords: Takeda Pharmaceuticals International GmbH, Waltham , Senior Manager, Global Regulatory Affairs CMC - Small Molecules, Other , Cambridge, Massachusetts

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

Warehouser - Earn $15.25/hr or more, plus benefits and a $1,000 sign-on bonus

Description: Seasonal Full-time Warehouse Team Member - 1000 sign-on bonus Hourly pay rate: Earn 15.25 - 18.25/hr, plus benefits and a 1,000 sign-on bonus. Limited Time Opportunity Location: Milford, (more...)

Company: 8162

Location: Woonsocket

Posted on: 09/15/2020

Amazon Workforce Staffing: Order Picker/Packer - 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: Woonsocket

Posted on: 09/15/2020

Amazon Workforce Staffing: Full-Time Warehouse Team Member - $500 Sign-On Bonus

Description: Full-time

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/15/2020

Amazon Warehouse Operator (Full-Time) - Day and Night Shifts Available - Up to$1000 sign on Bonus +

Description: Seasonal Full-time Warehouse Team Member - 1000 sign-on bonus Hourly pay rate: Earn 15.25 - 18.25/hr, plus benefits and a 1,000 sign-on bonus. Limited Time Opportunity Location: Milford, (more...)

Company: 8162

Location: Woonsocket

Posted on: 09/15/2020

Amazon Warehouse Assistant (Full-Time) - Day and Night Shifts Available - Up to$1000 sign on Bonus +

Description: Seasonal Full-time Warehouse Team Member - 1000 sign-on bonus Hourly pay rate: Earn 15.25 - 18.25/hr, plus benefits and a 1,000 sign-on bonus. Limited Time Opportunity Location: Milford, (more...)

Company: 8162

Location: Woonsocket

Posted on: 09/15/2020

Amazon Workforce Staffing: Seasonal Part-Time Amazon Warehouse Operator - $1000 Sign-On Bonus

Description: Seasonal Part-time

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/15/2020

Finance Director - PBM

Description: FEI Career Center is part of the FEI Affinity Programs Solutions Portfolio, a collection of essential business solutions for finance professionals. Learn more about FEI Affinity Programs Solutions. (more...)

Company: CVS Caremark

Location: Woonsocket

Posted on: 09/15/2020

Warehouse Attendant (Weekend/Weekday Shifts Available) - Up to $1000 sign onBonus + Benefits

Description: Seasonal Full-time Warehouse Team Member - 1000 sign-on bonus Hourly pay rate: Earn 15.25 - 18.25/hr, plus benefits and a 1,000 sign-on bonus. Limited Time Opportunity Location: Milford, (more...)

Company: 8162

Location: Woonsocket

Posted on: 09/15/2020

Amazon Workforce Staffing: Seasonal Reduced-Time Amazon Warehouse Worker With Bonus Potential And Be

Description: Seasonal Part-time Warehouse Team Member 1000 sign-on bonusHourly pay rate:Earn 15.25/hr or more, plus benefits and a 1000 bonus Limited Time OpportunityLocation:Milford, MAJob opportunities vary (more...)

Company: Amazon Workforce Staffing

Location: Woonsocket

Posted on: 09/15/2020

Warehouser (Weekend/Weekday Shifts Available) - Up to $1000 sign on Bonus +Benefits

Description: Seasonal Full-time Warehouse Team Member - 1000 sign-on bonus Hourly pay rate: Earn 15.25 - 18.25/hr, plus benefits and a 1,000 sign-on bonus. Limited Time Opportunity Location: Milford, (more...)

Company: 8162

Location: Woonsocket

Posted on: 09/15/2020

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 , Senior Manager,Global Regulatory Affairs CMC, 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


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

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


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 Order Filler (Part Time)
Description: Schedule: br 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 (more...)
Company: Amazon
Location: Weymouth
Posted on: 09/20/2020

Amazon Workforce Staffing: Seasonal Part-Time Warehouse Team Member - $500 Sign-On Bonus
Description: Seasonal Part-time Warehouse Team Member 500 sign-on bonusHourly pay rate:Earn 15.25- 18.25/hr, plus benefits and a 500 bonus The base pay for this role is 15.25/hr. We are offering temporary shift (more...)
Company: Amazon Workforce Staffing
Location: Taunton
Posted on: 09/20/2020

Short Shifts, Great Pay - In Home Caregiver
Description: No Certification No Problem We are hiring caregivers of all skill levels to provide compassionate In Home Care to
Company: CareInHomes
Location: Concord
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

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

Part-Time Amazon Package Sorter with 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

Log In or Create An Account

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

Cambridge RSS job feeds