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Associate Director Regulatory Strategy

2 months ago

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

Overview

Bicycle Therapeutics is seeking an experienced Regulatory Affairs professional to join our team as an Associate Director, Regulatory Affairs. This role will be responsible for developing and executing regulatory strategy for assigned BicycleTx programs or projects.

Key Responsibilities

  • Regulatory Strategy Development
    • Develop and execute regulatory strategy for assigned BicycleTx programs or projects, including development and maintenance of the Regulatory Plan.
    • Collaborate with cross-functional colleagues to ensure regulatory compliance and adherence to relevant regulatory requirements.
  • Regulatory Submissions
    • Oversee the preparation and execution of global regulatory submissions for assigned BicycleTx programs or projects.
    • Collaborate with the Regulatory Lead to ensure timely execution of regulatory submissions.
  • Regulatory File Maintenance
    • Maintain regulatory files and tracking databases, including relevant parts of the trial master file.
  • Collaboration and Communication
    • Collaborate with internal colleagues, external regulatory and quality consultants, and external organizations to support the timely execution of regulatory submissions.
    • Author responses to questions, audits, and inspections.
  • Submission Preparation
    • Manage the preparation, drafting, review, risk analysis, and mitigation planning of submissions for assigned BicycleTx programs or projects.
    • Develop and maintain internal cross-functional relationships to support the development and execution of regulatory strategy.
  • Regulatory Landscape Monitoring
    • Monitor the regulatory landscape to anticipate and adapt to changes that may impact assigned BicycleTx programs or projects.
  • Additional Responsibilities
    • May act as Global/Regional Regulatory Lead for assigned development programs.
    • May serve as primary contact with Health Authorities (HA) &/or external collaborators globally for assigned BicycleTx programs or projects.
    • May support the development of processes, SOPs, and other controlled documents, including for Regulatory Affairs activities.
    • May support preparations and attend regulatory authority meetings for assigned development programs.

Qualifications

  • Bachelor's degree in a scientific field or post-graduate degree preferred.
  • Extensive experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
  • Working knowledge of FDA, EMA, and ICH regulatory guidance and regulations.
  • Experience and knowledge in preparation of INDs, CTAs, NDAs, MAAs, or regional equivalents is required.
  • Experience and knowledge in supportive interactions with health authorities, including US FDA, EMA, and/or EU Member States, is desirable.
  • An understanding of the drug product lifecycle from discovery to clinical trials to marketing is required.
  • Experience and knowledge of some of the key regulatory pathways for product development, for example, pediatrics plans, orphan drugs, Regulatory Agency advice, expedited development (e.g., Fast Track, Breakthrough Designation, PRIME) is desirable.
  • Therapeutic experience in oncology is desirable.
  • Ability to communicate on topics of basic science is essential; a working knowledge of global drug development, including preclinical and clinical, is required.
  • Ability to proactively identify risks and develop risk mitigation strategies.
  • Adaptable and strategic thinker with the ability to generate creative solutions to complex problems, identifying 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.
  • Position may require some domestic and international travel.

Additional Information

  • State-of-the-art campus environment with on-campus restaurant and Montessori nursery.
  • Flexible working environment.
  • Competitive rewards, including annual company bonus.
  • Employee recognition schemes.
  • 28 days annual leave, in addition to bank holidays, with the option to buy up to 5 additional days annually.
  • Employer contribution to pension (employee does not have to contribute).
  • Life assurance cover 4x basic salary.
  • Private Medical Insurance, including optical and dental cover.
  • Group income protection.
  • Employee assistance program.
  • Health Cash Plan.
  • Access to company-subsidized gym membership.
  • Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
  • Cycle to work scheme.

Bicycle Therapeutics is an Equal Opportunities Employer

We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, color, gender, sexual orientation, age, disability status, marital status, or veteran status.