Wugen Inc. is seeking exceptional and highly motivated candidates to join our teams in San Diego and St. Louis. This candidate will provide regulatory leadership in support of all development programs at Wugen. This includes the development and implementation of regulatory strategy, ensuring timely preparation, review and submission of documents to regulatory authorities, and maintaining compliance with applicable regulatory requirements. This candidate represents the regulatory function on multi-disciplinary teams and must integrate company goals into the objectives and activities of the Regulatory Affairs Department.
- Lead the Regulatory Affairs function, including managing a small team.
- Develop and implement regulatory strategies for all company development programs.
- Manage the preparation and timely submission of documents to regulatory authorities (FDA, EMA and other national authorities), including INDs, CTAs, briefing documents for key meetings, responses to regulatory requests and BLAs.
- Serve as the primary point of contact for regulatory authority interactions, including the preparation and regulatory leadership for key meetings including Pre-IND, etc.
- Ensure that the content and format of regulatory submissions and amendments are in compliance with all applicable regulations and guidelines for cell and gene therapy products.
- Serve as the internal primary conduit on all Regulatory matters for senior leadership.
- Serve as the subject matter expert on US, EU, ICH and other applicable regulations, guidance documents, contemporary regulatory practices and relevant regulatory precedence to guide overall product and clinical development plans.
- Develop risk assessment scenarios and review mitigations and contingencies plans with multidisciplinary team.
- Collaborate with third party consultants and CROs to supplement expertise and operational capacity.
- Remain knowledgeable of current regulations and guidance, provide thoughtful interpretation of same and notify appropriate personnel.
- Develop, review and maintain Regulatory and other applicable SOPs and policies.
- Lead effective management of the Regulatory Affairs function, including budget administration, cost control, etc.
- Bachelor’s degree in biology or related field. Advanced degree, such as MS, PhD, PharmD preferred.
- 10+ years of direct experience in Regulatory Affairs in Biotech/Pharma for drugs and biologics. RAC certification desired.
- Must have some regulatory experience with biologic programs in oncology drug development. Cell/gene therapy experience is preferred.
- Experience developing and leading global regulatory strategies for INDs, CTAs, NDAs, MAAs and/or BLAs with a track record of successful approvals; knowledge of expedited programs like Breakthrough Therapy, PRIME, Orphan Drug Designation is desired.
- Strong knowledge of biopharmaceutical industry Regulatory Affairs throughout the product lifecycle, including Development, CMC, Labeling, Promotion, Commercialization, and Operations.
- Knowledge of clinical development, including responsibilities for successful management of development milestones and marketing authorization, meeting facilitation, deficiency letter and regulatory responses.
- Previous experience leading and managing a Regulatory team desired.
- Strong interpersonal skills with the ability to negotiate and influence others in a positive and effective manner.
- Capacity to react quickly and decisively in unexpected and dynamic situations.
- Ability to lead, provide direction and guidance, make decisions, think critically, solve problems and respond proactively.
- Must have excellent communication skills (both written and oral).
- Strong project management skills required.