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

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Keywords: Amazon. com Services LLC, Bellevue , Associate Director of Regulatory Affairs, Other , Sammamish, Washington