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Regulatory Operations Manager
2 months ago
Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Our team is seeking a highly skilled Regulatory Operations Manager to support the development, implementation, and management of our regulatory systems and operational processes.
The successful candidate will work closely with our Associate Director of Regulatory Operations to implement and maintain our Document Management, Regulatory Information, and Regulatory Publishing systems. They will be responsible for planning and executing all regulatory publishing activities for our programs, ensuring adherence to relevant regulatory requirements.
- Lead and manage planning, compilation, and publishing of global regulatory submissions in eCTD and non-eCTD formats
- Plan, manage, and track delivery of submission components, coordinating submission publishing activities
- Publish global regulatory submissions in eCTD and non-eCTD formats
- Support the implementation of our Document Management and Regulatory Information Management System
- Develop and improve associated internal operational processes and procedures, such as SOPs, Work Instructions, etc.
- Support the development and execution of training for all users of our regulatory systems
- Responsible for the maintenance of our regulatory information within the RIM System
- Collaborate with internal and external regulatory affairs and cross-functional colleagues to ensure the execution of regulatory submissions, including initial submissions, responses to questions, audits, and inspections
- Collaborate 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 change management, audits, and inspections
- Maintain oversight of current and pending relevant regulatory submissions, providing associated metrics, insights, and dashboards as needed
- Maintenance of all of our regulatory operations data and information, including regulatory requirements such as IDMP, SPOR, etc.
- Monitor the regulatory operations landscape to anticipate and adapt to changes that may impact assigned programs or projects
Requirements
- 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 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
What We Offer
- 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, plus 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 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, color, gender, sexual orientation, age, disability status, marital status, or veteran status.
