Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.
Regulatory Affairs . Bothell, Washington
Seattle Genetics is currently seeking a Senior Manager of Regulatory CMC located at either our South San Francisco, CA site or our Bothell, WA corporate headquarters. At Seattle Genetics, each person plays a critical role in advancing transformative therapies that improve the lives of people with cancer in a culture of integrity, scientific excellence, teamwork, innovation and mutual respect. Here's how you can make a difference:
About your role
The Regulatory CMC Senior Manager will provide leadership in a cross-functional team setting to develop and execute CMC regulatory strategies and provide regulatory guidance to biologics, antibody-drug conjugate, small molecule and novel modality project teams to ensure compliance with relevant regulations, guidelines, and industry standards. The successful candidate will plan, prepare, and gain appropriate internal review and approval of CMC-related regulatory documentation to ensure its suitability for submission to health authorities. He/she will also support regulatory affairs systems, such as change control and knowledge management.
Our ideal new colleague possesses strong interpersonal, listening and persuasive communication skills to give the best advice to internal stakeholders. They naturally strive for the best performance and have the willingness to learn. Additionally, they are good team players, dynamic, optimistic, accurate, result oriented, hard-working and creative.
Proactively manage Chemistry, Manufacturing & Controls (CMC) regulatory aspects of one or more biologic or small molecule products in early to late stage development through interaction with multiple functions to create high quality regulatory submissions that support a product development strategy that meets global regulatory requirements over the lifecycle of each product
Develop global regulatory CMC strategies for biologic and small molecule products to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information
Monitor, interpret, and provide guidance to CMC teams minimally on ICH, FDA, Health Canada and EU CMC guidelines and keep current with changing regulatory requirements and expectations such as developments in guidance, regulations, practices and policies concerning CMC topics
Lead the preparation of CMC components of regulatory submissions including clinical trial and variations/supplements as well as registration submission for major markets ensuring alignment with regulations, guidelines, policies and procedures
Lead the preparation of CMC aspects of documents for regulatory agency interactions and may represent Regulatory CMC in agency meetings
Lead and provide support for other post approval reporting to regulatory licenses, approved applications, and authorities including Annual Reports, Lot Distribution Reports, and Safety Reporting
Evaluate proposed manufacturing changes for global impact and provide strategic regulatory reporting strategies that support compliance change implementation
Develop and maintain integrated project plans and schedules for CMC submissions
Critically review regulatory submission documents, identifying gaps, risks and ambiguity and work with CMC teams to resolve gaps, risks and clarity of messaging
Develop and maintain excellent relationships with internal functional groups, contract manufacturing organizations and corporate partners to ensure alignment of regulatory CMC strategies and successfully accomplish regulatory goals
Represent the Regulatory Affairs CMC function on assigned cross-functional project teams
Review and provide comments on SOPs, product container labeling, product specifications, comparability protocols and reports, quality agreements, pharmacy manuals, investigator brochures, and other related CMC documents
Contribute to the improvement, design and implementation of Company Regulatory processes and procedures where appropriate.
Support PAI and launch activities as appropriate
Bachelor's degree or PhD (preferred) in Biology, Chemistry, Biochemistry, Bioengineering, or a related scientific field
8+ years of CMC experience in the biotechnology or pharmaceutical industry with a minimum of 3 years in CMC regulatory affairs; prior experience in cGMP and development and commercial phases of a product lifecycle is preferred
Must possess extensive knowledge and proven track record of successfully managing the preparation of CMC components of INDs, CTAs, MAAs, NDAs as well as the preparation and management of post approval CMC documentation in electronic CTD format
A strong scientific and technical background in biotechnology is essential as are analytical and interpretive skills for understanding of the scientific basis for product CMC strategy
Knowledge of U.S. and international regulatory requirements and the ability to apply knowledge both strategically and operationally
Experience leading interactions with Health Authorities is preferred
Must be able to work effectively in a highly matrixed team-oriented structure using excellent communication, interpersonal and relationship management skills to successfully interact with Regulatory, Technical Operations staff (Manufacturing, Analytical and Process Development, Quality Assurance and Quality Control) and partner stakeholders
Excellent oral and written communication skills:
Ability to read and interpret complex business and/or technical documents;
Ability to write comprehensive reports and detailed business correspondence;
Proficiency in speaking, comprehending, reading and writing English
Detail-oriented, with good organizational, time management and project management skills
Active learner, seeking and leveraging opportunities to gain new skills, knowledge, and experiences
Ready to embrace a culture of flexibility and innovation, with a very high degree of urgency and commitment to translating ground-breaking science into therapies that transform patients' lives
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.