ShorelineRecruiter Since 2001
the smart solution for Shoreline jobs

Associate Director of Regulatory Affairs

Company: Amazon. com Services LLC
Location: Sammamish
Posted on: September 17, 2020

Job Description:

Associate Director of Regulatory Affairs Company: NewYorkLifeScience.com

Location: Seattle

Posted on: September 12, 2020

Job Description:

Associate Director, Regulatory Affairs, Europe Description

Seattle Genetics is an emerging global multi-productbiotechnology company that develops and commercializes innovativetherapies for the treatment of cancer. The company’sindustry-leading antibody-drug conjugate (ADC) technology harnessesthe targeting ability of antibodies to deliver cell-killing agentsdirectly to cancer cells. In addition to two marketed products, weare advancing a strong product pipeline of novel therapies forsolid tumors and blood related cancers designed to addresssignificant unmet medical needs and improve treatment outcomes forpatients. More information about Seattle Genetics can be found atwww.seattlegentics.com

Position Summary

Reporting to the Senior Director of EU/RoW Regulatory Affairs,and in accordance with the goals of the company, and applicableregulations, standards, established procedures and plannedobjectives, the Associate Director of Regulatory Affairs will beresponsible for developing regulatory strategies, and planning,managing and executing regulatory activities for drug products inthe EU/Switzerland/UK.

Develop European regulatory strategies and work with the SrDirector of Regulatory Affairs and global Regulatory team towardsthe development of global regulatory strategies.

Provide strategic input to the Global Regulatory Team for allEurope-based Regulatory Affairs matters, including the seeking ofScientific Advice, MAA submissions, ODD, PIPs, as needed.

Define the strategy for and lead the MAA submission proceduresin the EU, Switzerland, UK (post-Brexit) for an NME inoncology.

Define and execute strategies for regulatory maintenancesubmissions (amendments, notifications, variations, renewals,annual updates) for drug products in Europe; as needed, work withregulatory affairs consultants/contractors, submit regulatorydocumentation and act as primary contact with the EMA and EUNational Competent Authorities (NCAs) as needed.

Supervise CTA Manager(s), responsible for CTAsubmissions/maintenance.

Serve as a liaison with the EMA and NCAs to support effectivecollaborations.

Educate project teams on the European regulatory pathways andrequirements to ensure effective product development andregistration.

Maintain an effective archiving system.

Ensure that the pharmaceutical products distributed in Europemeet EMA/ICH/NCA requirements and support the local commercialorganizations.

In partnership with other regulatory staff, maintain and expandcurrent knowledge of regional regulatory requirements andprecedents, including new regulations and laws, that may affect theclinical development and commercialization of company products.

Provide training on specific regulatory topics.

Support contractor selection and coordination of contractedactivities.

Performs other duties as required.

Qualifications:

PharmD, PhD, Masters or Bachelors degree in life sciences.

Minimum of 7 years of Regulatory experience, with at least 5years in a similar EU-based strategic role.

EU Centralized Procedure experience required (preferably an MAA,or as a minimum, major Type II Variations for new indications).

Ability to oversee regulatory activities and manage process fromresearch/discovery, clinical development through tocommercialization and post-marketing maintenance.

Experienced with CTA submissions and maintenance, as well asPIPs, Scientific Advice and Orphan Drug Designations.

Knowledge of EU procedures (fast to market procedures would bean advantage).

Familiarity with FDA IND/NDA/BLA, National European (Swiss, UK,others) regulatory processes preferred.

Regulatory project management experience.

Demonstrated leadership to drive results that are needed toachieve company objectives.

Proven ability to work with a high level of integrity, withstrong organizational skills to maintain a high level ofproductivity, innovation, and priority-setting.

Must possess excellent interpersonal skills.

Must have the ability to build and maintain positiverelationships with management, peers, and direct reports.

Ability to build/forge relationships with key stakeholders.

Excellent written and verbal skills required. Fluent English(spoken and written).

Must display strong analytical and problem solving skills.Attention to detail essential.

Self-motivated, assertive and confident with the ability to actwith urgency and passion.

Positive and resilient in outlook, and a drive to contribute tothe company, and grow in the process.

Entrepreneurial, enjoys working in a fast-paced, small-companyenvironment.

Flexibility in handling work-flow in a multi-taskingenvironment.

Ability to balance regulatory objectives with businessneeds.

As a leading employer in our industry, Seattle Genetics is proudto offer a competitive total compensation package as well as acomprehensive benefits program designed to support the whole livesof our employees and their families. To learn more about SeattleGenetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualifiedapplications will receive consideration for employment.

Seattle Genetics is an Equal Opportunity Employer

NewYorkLifeScience.com, owned and published by Info.Resource,Inc. , is a resource

for the life science industry in the state of New York.

Keywords: NewYorkLifeScience.com, Seattle , Associate Director of Regulatory Affairs, Other , Seattle, Washington

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

Warehouse Team Member (Different Shifts Available) - Plus Benefits and a $500Bonus

Description: Seasonal Part-time Warehouse Team Member - 500 sign-on bonus Hourly pay rate: Earn 15.20 - 16.45 , plus benefits and a 500 bonus Limited-time opportunity. Location: Kent, Renton Job (more...)

Company: 8162

Location: Sammamish

Posted on: 09/14/2020

Amazon Warehousing Worker (Different Shifts Available) - Plus Benefits and a $500 Bonus

Description: Seasonal Part-time Warehouse Team Member - 500 sign-on bonus Hourly pay rate: Earn 15.20 - 16.45 , plus benefits and a 500 bonus Limited-time opportunity. Location: Kent, Renton Job opportunities (more...)

Company: Amazon

Location: Sammamish

Posted on: 09/14/2020

Amazon Warehouse Assistant (Seasonal Part-time) - with Sign-on Bonus!

Description: Seasonal Part-time Warehouse Team Member - 500 sign-on bonus Hourly pay rate: Earn 16.80/hr- 17.80/hr, plus benefits and a 500 bonus Limited-time opportunity. Location: Sumner (more...)

Company: Amazon

Location: Sammamish

Posted on: 09/14/2020

Amazon Warehouse Attendant (Full-Time) - With $500 Sign-on Bonus

Description: Full-time Warehouse Team Member - 500 sign-on bonus Hourly pay rate: Earn 17.30 - 18.45, plus benefits and a 500 sign-on bonus. Limited-time opportunity. Location: Kent Job (more...)

Company: Amazon

Location: Sammamish

Posted on: 09/14/2020

Amazon Warehousing Worker (Different Shifts Available) - Plus Benefits and a$500 Bonus

Description: Seasonal Part-time Warehouse Team Member - 500 sign-on bonus Hourly pay rate: Earn 15.20 - 16.45 , plus benefits and a 500 bonus Limited-time opportunity. Location: Kent, Renton Job (more...)

Company: 8162

Location: Sammamish

Posted on: 09/14/2020

Warehouser (Part-Time)

Description: Seasonal Part-time Warehouse Team Member - 500 sign-on bonus Hourly pay rate: Earn 15.20 - 16.45 , plus benefits and a 500 bonus Limited-time opportunity. Location: Kent, Renton Job opportunities (more...)

Company: Amazon

Location: Sammamish

Posted on: 09/14/2020

Warehouse Operator (Part-Time) - Earn up to $16.3/hr - Plus Benefits

Description: Part-time Warehouse Team Member - 250 sign-on bonus Hourly pay rate: Earn 16.30 - 19.30/hr , plus benefits and a 250 bonus The base pay for this role is 16.30/hr. We are offering temporary (more...)

Company: 8162

Location: Sammamish

Posted on: 09/14/2020

Amazon Warehouse Assistant (Full-Time) - Up to $500 sign on Bonus + Benefits - Earn up to $17.3/hr

Description: Full-time Warehouse Team Member - 500 sign-on bonus Hourly pay rate: Earn 16.30 - 17.30 plus benefits and a 500 sign-on bonus Limited-time opportunity. Location: Sumner Job opportunities (more...)

Company: Amazon

Location: Sammamish

Posted on: 09/14/2020

Amazon Warehouse Assistant (Seasonal Part-time) - Up to $500 sign on Bonus - Earn up to $16.8/hr

Description: Seasonal Part-time Warehouse Team Member - 500 sign-on bonus Hourly pay rate: Earn 15.80 - 16.80, plus benefits and a 500 bonus Limited-time opportunity. Location: Sumner Job (more...)

Company: Amazon

Location: Sammamish

Posted on: 09/14/2020

Warehouse Laborer (Part-Time) - Benefits Included - Earn $19.3/hr

Description: Part-time Warehouse Team Member - 250 sign-on bonus Hourly pay rate: Earn 17.30 - 20.30/hr , plus benefits and a 250 sign-on bonus. The base pay for this role is 17.30/hr. We are offering (more...)

Company: Amazon

Location: Sammamish

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. com Services LLC, Shoreline , Associate Director of Regulatory Affairs, Other , Sammamish, Washington

Click here to apply!

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

I'm looking for
in category
within


Other Other Jobs


Surface Warfare Officer
Description: ABOUT America's Navy has the most modern, advanced fleet of ships in the entire world. Surface Warfare Officers SWOs are trained extensively to maintain and operate these ships, their crews and their (more...)
Company: Navy
Location: Redmond
Posted on: 09/27/2020

Get New Siding Work Today - Preview Leads In Your Area
Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement
Company: HomeAdvisor
Location: Redmond
Posted on: 09/27/2020

Certified Medical Assistant or LPN, Redmond Primary Care, $3,000 Sign-on Bonus
Description: Certified Medical Assistant or LPN- Full-time Redmond Primary Care Clinic Occasional floating to Kirkland Primary Care as needed ICARE Integrity Compassion Agility Respect Engagement (more...)
Company: Overlake Medical Center
Location: Redmond
Posted on: 09/27/2020


Delivery Driver - Earn $18.00 to $19.25++/hr
Description: Job DescriptionLocation : DWA9 3711 142nd Avenue East Sumner,WA 98390-9605 17.00- 18.25/hr 1/hr until 10/17 Amazon Delivery Service Partners are seeking bright, motivated, hardworking individuals (more...)
Company: Amazon Contracted Delivery Partners
Location: Redmond
Posted on: 09/27/2020

Speaker- Spanish Accent
Description: Requirement 1 6 Speakers Start Date ASAP Duration 1-3 months 11 Male Female Part-Time 6 hours
Company: ZEN3 INFOSOLUTIONS AMERICA INC
Location: Redmond
Posted on: 09/27/2020

Customer Service Representative - Work from Home - USA
Description: Join our TTEC work from home customerservice representative team if you reside 45 out of 50 states. We cannotaccept applications for residents of CA, CO, HI, IL or NY or outside of the UnitedStates. (more...)
Company: TTEC
Location: Sammamish
Posted on: 09/27/2020

OMC Medical Assistant, OB/GYN (Redmond & Newcastle) and Newcastle PC, Full-time, $3,000 Sign On Bonu
Description: OB/GYN Redmond amp Newcastle and Newcastle PC, Full-time 10 Hour Shifts ICARE Integrity Compassion Agility Respect Engagement This will be a full-time position, Monday-Friday (more...)
Company: Overlake Medical Center
Location: Redmond
Posted on: 09/27/2020

General Dentist
Description: JOB TITLE: General Dentist REPORTS TO: Lead Dentist/Regional Dental Director FLSA: Exempt Welcome to Preventistry-- We are revolutionizing oral health for everyone by redefining prevention and care. A (more...)
Company: Advantage Dental
Location: Redmond
Posted on: 09/27/2020

Delivery Driver - DSE4 - Everett, WA $17.00-$18.25/hr++
Description: Job DescriptionLocation : DSE4 6611 Associated Blvd. Everett WA 98203 17.00- 18.25/hr Amazon Delivery Service Partners are seeking bright, motivated, hardworking individuals to fill Contracted Delivery (more...)
Company: Amazon Contracted Delivery Partners
Location: Redmond
Posted on: 09/27/2020

Customer Support
Description: Work-From-Home English/Mandarin This is a bi-lingual position that requires fluency in English and Mandarin, both written and verbal. Applicants will be tested on their level of proficiency. This is a (more...)
Company: Comtek-group
Location: Sammamish
Posted on: 09/27/2020

Log In or Create An Account

Get the latest Washington jobs by following @recnetWA on Twitter!

Shoreline RSS job feeds