Senior Scientist, Regulatory Affairs- CMC - Synthetic Moieties of ADC's and Bioconjugates

Job Description SENIOR SCIENTIST (R3) REGULATORY CMC - SYNTHETIC MOIETIES OF ADCs AND BIOCONJUGATESPosition

Description:

Serve as a Regulatory Chemistry, Manufacturing and Control (CMC) Lead for the synthetic-moiety (Drug-Linker) of assigned antibody-drug conjugate (ADC) and other bio-conjugate programs, providing regulatory leadership within Regulatory and on cross-functional  accountable for the delivery of all regulatory milestones through product development and post-approval lifecycle.

Develop and execute robust, phase-appropriate global Regulatory CMC strategies for drug-linkers, payloads, linkers, peptides, and other chemically synthesized moieties that are part of bio-conjugate  accountable for the execution of global product regulatory strategies by robust assessment of global regulatory CMC requirements and identification of potential risks.

Integrate the regulatory strategy for synthetic moieties with those for the targeting component, conjugation process, conjugated drug substance, and drug product, including alignment of dossier content, data requirements, and regulatory milestones.

Manage preparation and execution of Chemistry, Manufacturing and Control documentation including Investigational New Drug Applications, Investigational Medicinal Product Dossiers, original Biologics License Applications, Marketing Authorization Applications, post-approval submissions/variations, agency meeting background packages, and responses to health authority questions.

Manage change controls and develops regulatory filing strategies with an understanding of regulations and company policies and procedures.

Conduct all activities with an unwavering focus on compliance

Position

Qualifications:

Education Minimum Requirement:

B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Chemistry, Chemical Engineering, or Biochemistry.

Required

Experience and Skills:

At least 5 years of Regulatory CMC or directly relevant pharmaceutical development experience in small molecules or other chemically synthesized modalities, including experience in process chemistry, analytical development, manufacturing, testing, quality, technical operations, or CMC product development.

Preferred

Experience and Skills:

Experience supporting CMC regulatory submissions, health authority interactions, or development of drug-linkers, payloads, ADCs, peptides, oligonucleotides, or other bio-conjugate or new-modality products.

Experience with external development or manufacturing partners and global life-cycle management is also preferred.

Required Skills:

Adaptability, Adaptability, Analytical Biochemistry, Analytical Chemistry, Antibody Drug Conjugates (ADC), Biochemistry, Bioconjugation, Chemistry, Detail-Oriented, Document Coordination, Drug Development, Drug Formulations, Electronic Common Technical Document (eCTD), Employee Training Programs, External Manufacturing, Interpersonal Relationships, Ligand Binding, Pharmaceutics, Process Chemistry, Regulatory Affairs Management, Regulatory CMC, Regulatory Communications, Regulatory Compliance, Regulatory Compliance Audits, Regulatory Documents {+ 6 more}Preferred

Skills:

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