Senior Manager Regulatory Affairs CMC

Bicycle Therapeutics; England; Hybrid; GBP 70,000 - 90,000; Full time

Job summary

A clinical-stage pharmaceutical company in the UK is seeking a Senior Manager in Regulatory Affairs CMC. This role involves developing and executing CMC regulatory activities, collaborating with cross-functional teams, and ensuring compliance with regulatory requirements. Candidates should have strong experience in CMC and clinical regulatory affairs, with a focus on peptides and drug-conjugates. This position allows for a hybrid working arrangement with a minimum of onsite presence from the Cambridge office.

Benefits

Competitive reward including annual company bonus

28 days annual leave

Employer contribution to pension

Private Medical Insurance

Cycle to work scheme

Qualifications

• Must have CMC and Clinical Regulatory Affairs experience.
• Experience preparing CMC sections of INDs, CTAs, NDAs is required.
• Strong relationship building skills with partners.

Responsibilities

• Responsible for the development and execution of regulatory strategy and submissions.
• Collaborate to develop submission content plans and timelines.
• Manage preparation and review of CMC submissions.

Skills

Strong experience in CMC Regulatory Affairs

Demonstrated experience with peptides

General clinical regulatory experience

Working knowledge of FDA, EMA, ICH regulations

Ability to communicate scientific topics

Strong organizational skills

Adaptability to changing priorities

Ability to identify risks and mitigation

Education

Bachelor's degree in a scientific field

Job description

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Company Description

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. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilise their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle® Drug Conjugate (BDC®) targeting Nectin‑4, a well‑validated tumour antigen; BT5528, a BDC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumour‑Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin‑4 and agonising CD137, in company‑sponsored clinical trials. Additionally, the company is developing Bicycle® Radioconjugates (BRC®) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology.

Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Mass. For more information, visit bicycletherapeutics.com.

Job Description

The Senior Manager, Regulatory Affairs CMC will be responsible for the development, execution and tracking of CMC regulatory activities for assigned BicycleTx programmes or projects.

You will be responsible for supporting the development of CMC regulatory strategy and processes for their assigned BicycleTx programmes or projects, working closely with cross‑functional colleagues and the Director, Regulatory Affairs CMC. As an integral member of the team that will be tasked with CMC product development, the Senior Manager, Regulatory Affairs CMC will also serve as a subject matter expert (SME) for assigned activities, which may involve multiple partners and collaborators, and will ensure adherence to relevant regulatory requirements.

Key Responsibilities

• Responsible for the development and execution of regulatory strategy and submissions for assigned BicycleTx programmes or projects, with a focus on regulatory CMC, including dossiers to support clinical trial applications
• Responsible for the regulatory assessment of change controls, maintenance of regulatory files and tracking databases related to CMC submissions
• Collaborate with internal colleagues and external organisations to develop submission content plans and timelines and support the timely execution of regulatory submissions that require CMC content, responses to questions, audits and inspections
• Manage the preparation, drafting, review, risk analysis and mitigation planning of CMC submissions (e.g. Module 3 IND, IMPD, amendments and annual reports) for assigned BicycleTx programmes or projects
• Developing and maintaining internal cross‑functional relationships to support the development and execution of CMC regulatory submissions for assigned BicycleTx programmes or projects
• May act as the Global/Regional CMC Regulatory Lead for assigned development programmes
• May support the development of processes, SOPs and other controlled documents, including for Regulatory Affairs activities
• Partners with Regulatory Affairs and cross‑functional colleagues to understand the CMC regulatory landscape, e.g., views of HAs, regulatory precedents, labelling differences and other CMC‑specific issues and adapts to changes that may impact BicycleTx programmes or projects
• Accountable for maintaining working knowledge of CMC laws, guidances and requirements relevant to assigned BicycleTx programmes or projects, 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 that can commit to a minimum of 0.8FTE (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; any in‑depth experience may be limited to one specific region (e.g. US or EU).
• 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 the supportive interactions with health authorities, including US FDA, EMA and/or EU Member States, is desirable
• 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; 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 programme goals for assigned BicycleTx programmes or projects
• 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 recognise 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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