Associate Director, Regulatory Affairs CMC

3 weeks ago

Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time
Job Description

The Associate Director, Regulatory Affairs CMC will be responsible for the development, strategy, execution, and tracking of CMC regulatory activities for assigned BicycleTx programs or projects.

This role will support the delivery of CMC regulatory strategy and submissions for their assigned BicycleTx programs or projects, working closely with cross-functional colleagues and the Senior Director, Regulatory Affairs CMC.

Key Responsibilities:
  • Develop and execute global regulatory CMC strategy and submissions for assigned BicycleTx programs or projects, including CMC dossiers to support clinical trial applications.
  • Assess and manage regulatory change controls, maintain regulatory files, and track databases related to CMC submissions.
  • Collaborate with internal colleagues and external organizations to develop submission content plans and timelines and support the timely execution of regulatory submissions that require CMC content.
  • Author responses to questions, audits, and inspections, and manage the preparation, drafting, review, risk analysis, and mitigation planning of CMC submissions.
  • Develop and maintain internal cross-functional relationships to support the development and execution of CMC regulatory submissions for assigned BicycleTx programs or projects.
  • Act as the Global/Regional CMC Regulatory Lead for assigned development programs.
  • Support preparations and attend regulatory authority meetings for assigned development programs.
  • Develop processes, SOPs, and other controlled documents, including for Regulatory Affairs activities.
  • Monitor the CMC regulatory landscape to anticipate and adapt to changes that may impact assigned BicycleTx programs or projects.
Qualifications:
  • Bachelor's degree in a scientific field or post-graduate degree preferred.
  • Extensive experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry, particularly relating to peptides, drug-conjugates, and/or radiopharmaceuticals.
  • Working knowledge of FDA, EMA, ICH, and cGMP CMC regulatory guidance and regulations.
  • Experience and knowledge in preparation of CMC sections of INDs, CTAs, NDAs, MAAs, or regional equivalents required.
  • Experience and knowledge in supportive interactions with health authorities, including US FDA, EMA, and/or EU Member States, desirable.
  • Ability to communicate on topics of basic science essential; an understanding of the drug product lifecycle from discovery to clinical trials to marketing required.
  • Ability to proactively identify risks and develop risk mitigation strategies.
  • Adaptable with the ability to generate creative solutions, identify different and novel ways to find solutions, and adapt to changing priorities and deadlines.
  • Highly collaborative, strong relationship building skills with internal and external partners, with a high level of integrity.
  • Works proactively using solid communication and influencing skills to effectively execute program goals for assigned BicycleTx programs or projects.
  • Works effectively in a highly complex and fast-paced environment.
  • Strong organizational and time management skills.

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