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 Lexington, MA.
Culture
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 Senior Manager, Regulatory Affairs CMC will be responsible for the development, execution and tracking of CMC regulatory activities for assigned BicycleTx programs or projects. You will support the development of CMC regulatory strategy and processes for your assigned programs, working closely with cross‑functional colleagues and the Director, Regulatory Affairs CMC. As an integral member of the CMC product development team, you will serve as a subject‑matter expert for assigned activities, may involve multiple partners and collaborators, and will ensure adherence to relevant regulatory requirements.
Key Responsibilities
* Develop and execute regulatory strategy and submissions for assigned BicycleTx programs or projects, focusing on CMC, including dossiers to support clinical trial applications.
* Assess change controls, maintain regulatory files and tracking databases related to CMC submissions.
* Collaborate with internal colleagues and external organizations to develop submission content plans and timelines, and support the timely execution of regulatory submissions, responses to questions, audits and inspections.
* Prepare, draft, review, perform risk analysis and mitigation planning of CMC submissions (e.g., Module 3 IND, IMPD, amendments and annual reports) for assigned programs.
* Develop and maintain internal cross‑functional relationships to support the development and execution of CMC regulatory submissions.
* Possibly act as the Global/Regional CMC Regulatory Lead for assigned development programs.
* Support the development of processes, SOPs and other controlled documents, including for Regulatory Affairs activities.
* Partner with Regulatory Affairs and cross‑functional colleagues to understand the CMC regulatory landscape, including views of health authorities, regulatory precedents, labeling differences, and other CMC‑specific issues.
* Maintain working knowledge of CMC laws, guidances and requirements relevant to assigned programs, in addition to general regulatory knowledge.
This is a hybrid working arrangement, with a minimum of 1‑2 days onsite from our Cambridge, UK office. We are also open to those who can commit to a minimum of 0.8 FTE (4‑day week). We are only considering candidates who have a mix of CMC and Clinical Regulatory Affairs experience.
Qualifications
Key Skills and Competencies
* Bachelor’s degree in a scientific field or post‑graduate degree preferred.
* Strong, demonstrable experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry, particularly relating to peptides and drug‑conjugates; in‑depth experience may be limited to one specific region.
* General clinical regulatory experience supporting global clinical trial applications (not limited to CMC) is essential.
* Working knowledge of FDA, EMA, ICH and cGMP CMC regulatory guidance and regulations.
* Experience and knowledge in preparation of CMC sections of INDs, CTAs, NDAs, MAAs or regional equivalents is required.
* Experience and knowledge in supportive interactions with health authorities, including US FDA, EMA and/or EU Member States, is desirable.
* 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; a working knowledge of global drug product development is required.
* Ability to proactively identify risks and develop risk mitigation strategies.
* Adaptable with the ability to generate creative solutions, identify different and novel ways to find solutions, and adapt to changing priorities and deadlines.
* Highly collaborative, strong relationship‑building skills with internal and external partners, with a high level of integrity.
* Works proactively using solid communication and influencing skills to effectively execute program goals for assigned programs.
* Works effectively in a highly complex and fast‑paced environment.
* Strong organisational and time‑management skills.
* Position may require some domestic and international travel.
Additional Information
* State‑of‑the‑art campus environment.
* Competitive reward including annual company bonus.
* 28 days annual leave in addition to bank holidays.
* Employer contribution to pension (employee does not have to contribute).
* Life assurance cover 4x basic salary.
* Private Medical Insurance, including optical and dental cover.
* Health Cash Plan.
* 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.
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