• Collaborate with biologics process development and analytical operations teams to ensure the use of efficient experimental approaches to facilitate establishment, alignment, and maintenance of biologics drug substance and drug product control strategies to meet current and upcoming regulatory requirements.
• Support subject matter experts (SMEs) in drafting of Module 3 (CMC) sections of clinical trial and marketing authorization applications and supplements (e.g. IND, IMPD, CTA, BLA, MAA, JNDA, CNDA).
• Collaborate with SMEs and contract manufacturing organizations (CMOs) to identify, track, archive, and monitor the availability of source documents supporting regulatory applications.
• Review draft CMC sections in collaboration with contributors and internal and external stakeholders for the appropriateness and accuracy of technical content.
• Working with regulatory CMC team and SMEs, identify and assess potential regulatory risks and influence teams to formulate phase-appropriate mitigation strategies.
• Support the maintenance of integrated control strategies throughout a program's life cycle.
• Relevant experience is required in executing biologics CMC regulatory strategy for submissions to health authorities in the US, EU and other regions.

Desired Skills & Experience

* 10+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry Regulatory Affairs experience with expertise working on developing Biologics, Biopharma, monoclonal antibody, or recombinant protein products.

* BS, MS, or Ph.D. in Biology, Biochemistry, Analytical Chemistry, Molecular Biology, or related Life Sciences/Scientific/Engineering field.

* Expertise supporting IND/BLA and related filings.

* Regulatory Affairs experience supporting regulatory approval process and submission from an early stage to approval.

* Experience interacting directly with global regulatory agencies including the FDA, and EMEA