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Regulatory Affairs ⋅ South San Francisco, California
Description Summary: Seattle Genetics is growing and actively seeking an Associate Director of Regulatory CMC to join our team at the Seattle or San Francisco site. 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. Both sites are located in thriving cities boasting high quality of life with easy access to cultural and sporting events as well as mountains and water. About your role You have the opportunity to join Seattle Genetics at time of pivotal growth and truly make a difference. In your role, you will provide leadership in a cross-functional team setting to develop and execute global 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 have oversight over the planning, preparation, and review of CMC-related regulatory documentation to ensure its suitability for submission to health authorities. He/she may have management responsibilities for staff. 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. Responsibilities:
Proactively manage Chemistry, Manufacturing & Controls (CMC) aspects of one or more products in early-to-late development through interaction with multiple functions to create high quality regulatory submissions that support product development strategy and ensure complete CMC content that meets current regional requirements
Compile, review and approve high quality CMC modules of development and marketing registration applications, amendments, and supplements for submission, ensuring complete CMC content that meets current regional requirements and with limited review rounds and FDA/Health Authority questions.
Evaluate proposed manufacturing changes for global impact to ongoing and existing filings, and providing strategic regulatory guidance for optimal implementation of changes
Research and interpret global CMC regulations and provide strategic direction and regulatory guidance to the Quality, Manufacturing, Process Development and other functional groups within the Technical Operations organization
Develop and implement innovative Regulatory submission and review processes for IND/IMPD/CTA/BLA/NDA and Health Authority feedback tracking to enable scale up of products developed by Seattle Genetics
Represent the Regulatory Affairs CMC function on assigned cross-functional project teams as well as at meetings with business partners and regulatory agencies for all CMC related issues
Manage interactions with global regulatory authorities for assigned projects to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which present CMC information
Develop excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners to effectively influence the implementation of optimum regulatory strategies
Provide strategic guidance for product development in alignment with global regulatory requirements for clinical development and registration of small molecule pharmaceuticals as well as lifecycle and change management of commercial biologic products.
Resolve complex CMC issues by demonstrating in-depth understanding of the regulations and industry drug development processes.
Reviews the regulatory submissions of other associates for thoroughness, accuracy, and timeliness.
BA/BS degree in life sciences in chemistry, molecular biology, immunology or similar is desirable. Ph.D. is preferred
At least 7 years of experience in Regulatory Affairs
At least 9 years in a related discipline in the pharmaceutical or biotechnology industry (preferably with exposure to cGMP and both development and commercial phases of product lifecycle)
Strong working knowledge of U.S. and EU regulatory requirements for biologics and small molecules, with preference for antibody drug conjugates
Experience in preparation of clinical trial applications, marketing applications, supplements, and/or Variations for pharmaceutical or biologic products in the U.S., Canada and Europe using eCTD format
Experience in assessing post-marketing changes
Outstanding interpersonal and communication (written and verbal) skills is required
Demonstrated ability to work within a cross-functional matrix team environment, such as cross-functional groups in Quality and Manufacturing, and including contractors, partners, and CRO's in the international markets
Highly organized, independent, self-motivated and able to meet deadlines
Proficiency with standard software prog
As the leading employer in our industry in the Pacific Northwest, Seagen 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 Seagen, please visit www.seagen.com. Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual