Senior Manager, Regulatory Affairs CMC

Our team are passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and autoimmune disease to deliver life-changing treatments to patients. Whilst working at Autolus you will enjoy a flexible, diverse and dynamic working environment which actively promotes creativity, leadership and teamwork – together we are ONE Autolus.

Autolus is a biopharmaceutical company, advancing innovative therapies at both clinical and commercial stages of development, focused on next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies, the company is engineering precisely targeted, controlled, and highly active T cell therapies designed to better recognize cancer cells, break down their defence mechanisms, and eliminate these cells. Autolus has a pipeline of product candidates in development for the treatment of haematological malignancies, solid tumours, and autoimmune diseases.

Our team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy and autoimmune diseases to deliver life-changing treatments to patients. While working at Autolus you will enjoy a flexible, diverse, and dynamic working environment which actively promotes creativity, leadership, and teamwork. In addition to this Autolus is proud to offer a competitive salary, performance-related bonus as well as private medical insurance, life insurance, and 401-k program.

Autolus is developing complex, breakthrough therapies for a globally diverse market and equally recognises that diversity amongst our people is critical to our mission. As we draw on our differences, what we’ve experienced, and how we work, we celebrate diversity and are committed to creating an inclusive environment for all employees.

With a significantly expanding regulatory team, an exciting opportunity has arisen for an experienced CMC Regulatory Affairs Senior Manager to join the Autolus team to work on innovative and pioneering products across Autolus’ cell and gene therapy portfolio. The Regulatory Affairs Senior Manager will be part of the CMC regulatory affairs team with responsibilities for planning, preparing and reviewing CMC content of regulatory applications to health authorities globally. The successful candidate will be involved with working on innovative and pioneering Advanced Therapy Investigational Medicinal Products (ATIMPs) to treat cancers and benefit from working with cutting edge technologies and be a key player in developing regulatory submissions and advancing Autolus’ innovative portfolio of products.

Key Responsibilities

• To plan, prepare, review CMC-related submission documentation and to provide input into and be accountable for the preparation of CMC dossiers for submission to Health Authorities (BLA / MAA / IND / CTA etc.) and notified bodies;
• Where appropriate, to act as the CMC Regulatory Lead on CMC Teams, representing the CMC Regulatory viewpoint and expertise on the CMC Team;
• To identify potential CMC regulatory risks to the strategic / operational plans and propose options to mitigate risks;
• To plan, prepare, review CMC components of briefing packages in connection with Health Authority scientific advice and submission meetings;
• Responsible for global regulatory evaluation of CMC change controls;
• Facilitate CMC submission document review meetings and discussions;
• To provide CMC Regulatory support to pre-approval and GMP inspections;
• Ensure compliance with Health Authority CMC related Regulations and ensure awareness of cell and gene therapy guidelines;
• Liaise with cross-functional CMC and manufacturing team members and external providers to ensure timely and effective regulatory submissions in support of product development progression and lifecycle management of the CMC dossier;
• Any other duties as required following consultation with the post holder;
• The post-holder will be responsible for adhering to all health and safety guidance, provided by the Company.

Demonstrated skills and competencies

• E – Essential
• P – Preferred
• Breadth of experience in Regulatory Affairs with a core expertise in CMC for biologics (E);
• Experience in CMC biologic drug development (E); experience in cell and gene therapies development (P);
• Good working knowledge of FDA and EU CMC regulations and guidelines related to biologics (E) and cell and gene therapies (P);
• Strong regulatory authoring expertise, willingness to support authoring of key regulatory documents (E) and experience with drafting CMC regulatory submissions, including IMPD Clinical Trial Authorisation (CTA) and IND applications and maintenance submissions (E), as well as US BLAs, EU MAAs (P) and their maintenance.
• Submissions with cell and or gene therapies (P);
• Experience with environmental risk assessments/GMO submissions for gene therapy products internationally (P);
• Proven regulatory project management expertise – coordinating and managing submissions activities across multiple projects (E);
• Strong communication skills and the ability to work collaboratively (E);

Qualifications

• Bachelor’s degree in Life Science (E) or Master/PhD (P).

Skills/Specialist knowledge

• In-depth understanding of FDA/EMA/ICH and other global regulatory requirements for CMC submissions.
• Experience with INDs, BLAs, MAA submissions, including post-approval maintenance of dossiers.
• Knowledge of cGMPs and a strong background in pharmaceutical development and manufacturing.
• Expertise in authoring and reviewing CMC sections of regulatory submissions (Module 3 of CTD/eCTD format).
• Experience of managing responses to Health Authority queries.
• Strong written and verbal communication skills for regulatory submissions and correspondence.

Autolus Core Competencies

• Focus on Results: Works to meet business goals set by management and leaders
• Builds Trust and Relationships: Ensures trust with internal and external partners by delivering on commitments
• Resilience: Has the capacity to recover quickly from difficulties; toughness
• Communicates and Collaborates: Builds partnerships and works collaboratively with others to meet objectives

Autolus’ success is driven by equality and inclusion; we believe all voices are of equal value and must be heard. Whilst operating with focus and integrity, we are committed to improving diversity and inclusion within our business and our industry.