Associate Director Regulatory Operations - Cambridge, United Kingdom - Bicycle Therapeutics

Bicycle Therapeutics

Verified Company

Cambridge, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

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 crossfunctional 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 crossfunctional 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 crossfunctional 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 indepth 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 fastpaced environment
Strong organizational and time management skills
Position may require domestic and international travel up to 10% of time

Additional Information

Stateoftheart 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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