Find More Than 10K+
United Kingdom Jobs

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical need. Bicycle is headquartered in Cambridge, UK, and our US operations run out of Cambridge, MA.

Culture is key and all Bicycle employees actively embrace and role model our company values:

• We are Adventurous. We believe it’s the way to deliver extraordinary results for our patients.
• We are Dedicated to our Mission. You can’t change the world if you don’t have determination.
• We are One Team. We only succeed when we work together.

The Associate Director of Regulatory Operations will be responsible for the development, implementation and management of BicycleTx regulatory systems and operational processes, reporting to the Head of Regulatory Affairs.

You will be responsible for the implementation of BicycleTx’s planned Document, Regulatory Information and Regulatory Publishing systems and associated operational processes (SOPs, etc.). Following implementation, you will be responsible for maintaining these systems, and for the planning and execution of all Regulatory publishing activity for BicycleTx’s programs. You will also serve as a subject matter expert (SME) for Regulatory Operations, which may involve multiple partners and collaborators, and will ensure adherence to relevant regulatory requirements.

KEY RESPONSIBILITIES

• Responsible for leading all regulatory operations and publishing activities for BicycleTx programs

• Responsible, through collaboration with external vendors, for the implementation of BicycleTx’s planned Document, Regulatory Information and Regulatory Publishing Systems; ensuring that this implementation meets all regulatory requirements, and BicycleTx’s business needs

• Responsible for the development or improvement of associated internal operational processes and procedures, such as SOPs, Work Instructions etc

• Responsible for the development and execution of training for all users of BicycleTx’s regulatory systems

• Responsible for the maintenance of BicycleTx’s regulatory systems, collaborating with internal and external colleagues, ensuring these continue to meet evolving regulatory requirements

• Responsible for the planning and execution of all Regulatory publishing activity for BicycleTx’s programs, in accordance with agreed timelines and regulatory requirements

• Collaborates with internal and external regulatory affairs and cross-functional colleagues, to ensure the execution of regulatory submissions, including, but not limited to, initial submissions, responses to questions, audits and inspections

• Collaborates with internal and external regulatory affairs and cross-functional colleagues, to ensure robust management and tracking of regulatory information to support key compliance activities including, but not limited to, change management, audits and inspections

• Collaborates with cross-functional colleagues, including IT, to support the development of BicycleTx’s systems infrastructure and technology

• Maintains oversight of current and pending relevant regulatory submissions, providing associated metrics and insights as needed

• Responsible for maintaining all of BicycleTx’s regulatory operations data and information, including regulatory requirements such as IDMP, SPOR etc

• Monitors the regulatory operations landscape to anticipate and adapt to changes that may impact assigned BicycleTx programs or projects

• 
  Demonstratable experience in Regulatory Operations within the pharmaceutical or biotechnology industry

• Working knowledge of FDA, EMA and ICH regulatory guidance and regulations, with in-depth knowledge of requirements for Regulatory Operations, including regulatory systems, publishing and data

• Experience and involvement in the implementation of regulatory systems, processes and procedures; and in the development and delivery of associated training

• Experience and knowledge in the preparation and publishing of regulatory submissions, such as INDs (in eCTD format), CTAs, or regional equivalents

• An understanding of the drug product lifecycle from discovery to clinical trials to marketing is required

• Ability to communicate on topics of basic science is essential

• Adaptable and strategic thinker with the ability to generate creative solutions to complex problems, identifying different and novel ways to find solutions

• Highly collaborative, strong relationship building skills with internal and external partners, with a high level of integrity; experience with vendor management is desirable

• 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 domestic and international travel up to 10% of time

• State-of-the-art campus environment with on campus restaurant and Montessori nursery
• Flexible working environment
• Competitive reward including annual company bonus
• Employee recognition schemes
• 28 days annual leave in addition to bank holidays + 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
• Enhanced parental leave policies
• 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 committed to building a diverse workforce that is representative of the communities we serve. 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, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.