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Regulatory Operations Manager
2 months ago
Bicycle Therapeutics is seeking a highly skilled Regulatory Operations Manager to support the development, implementation, and management of our regulatory systems and operational processes. As a key member of our team, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the successful execution of our regulatory submissions.
Key Responsibilities- Regulatory Systems Management
- Lead and manage the planning, compilation, and publishing of global regulatory submissions in eCTD and non-eCTD formats.
- Plan, manage, and track the delivery of submission components, coordinating submission publishing activities.
- Regulatory Information Management
- 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.
- Training and Development
- Support the development and execution of training for all users of our regulatory systems.
- Regulatory Compliance
- 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.
- Regulatory Operations
- 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.
- 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.
- 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 + 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.
