Regulatory Affairs Lead, Chemistry, Manufacturing Controls

About Astellas:

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

The Opportunity:

As the Regulatory Affairs Lead, Chemistry, Manufacturing and Controls you will be responsible for developing regulatory CMC strategy for assigned projects. You will identify and collect CMC data required for regulatory submission packages. You will plan and prepare CMC regulatory packages, assess changes for potential regulatory impact, responds to action letters, and maintain filings and approvals.

You will also utilize your working knowledge of CMC to effectively interpret CMC development and changes and determine the impact on the project or product and the application.

Hybrid Working:

At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.

Key Responsibilities:

• Act as CMC regulatory lead or deputy for complex projects/products, requiring advice from the manager on complex issues.
• Manage technical documents for preparation, review, and submission to regulatory agencies. Prepares INDs/CTAs NDAs/MAAs, amendments supplements, as well as responses to questions from regulatory agencies.
• Assesses scientific data against regulatory requirements and reviews submissions against regulatory strategy.
• Ensures proper CMC Dossier Management, including document version control.
• Ensure compilation and transmittal of submissions are within defined schedules and meet Health Authority and Astellas established standards/SOPs.
• Develop an approach for new assignments having less-defined regulatory frameworks with management oversight.
• Interact regularly with functional peer groups internally and externally, occasionally with senior management.
• Advise local teams on regulatory requirements. Interprets and ensures compliance with applicable Health Authority/ICH regulations.

Essential Knowledge Experience:

• Proven expertise in an aspect of pharmaceutical drug development.
• Knowledge of Health Authority and ICH regulations and guidelines, and the ability to provide interpretations of that information to others.
• Strong organizational skills with the ability to manage large projects and provide regulatory guidance/training to others in the department as needed.
• Proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members.
• Effective written and oral communication skills, with writing ability to meet regulatory requirements and standards.
• Ability to communicate effectively and maintain effective working relationships. Must be able to influence department staff and other Astellas groups positively.
• Fluent in written and spoken business English.

Preferred Knowledge Experience:

• Extensive and relevant experience in product development in the manufacturing or regulatory field.
• Advanced collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast-paced environment.
• Able to manage complex projects by exercising independent decision-making and analytical thinking skills.
• Knowledge or proven experience of Health Authority regulations, guidelines, and regulatory processes for NCEs, NBEs, and product life cycle maintenance.
• Ability to work in cross-functional and international environments, detail and goal-oriented, quality-conscientious, and customer-focused.
• Proven experience in biologics, vaccines, cell/gene therapy, or medical devices is preferred.

Education/Qualifications:

• Master’s Degree, or equivalent.

Additional Information:

• This is a permanent, full-time position.
• This position is based in the United Kingdom.
• This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per week in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.