Associate Director Regulatory Operations
3 weeks ago
Company Description
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.
**Job Description**:
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.
**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
**Qualifications**:
- 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
Additional Information
- 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
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