Purpose and Scope:

This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. Responsible for multiple regulatory activities in collaboration with stakeholders (e.g., other RA functions, Pharmaceutical Technology, Quality Assurance, Business Partners). Responsible for developing global CMC regulatory strategy (e.g., CMC strategy/planning for NMEs), driving global CMC RA related activities and successfully executing regulatory strategies in collaboration with stakeholders. Responsible for supporting business critical interactions inside and outside of Astellas Regulatory Affairs on complex CMC issues and questions in collaboration with local and global stakeholders.

Responsibilities and Accountabilities:

• Acts as a CMC regulatory lead for highly complex projects/products and/or participates in non-product or overarching related activities.
• May manage a small team or act as a mentor for one or more people.
• Acts as CMC regulatory expert by global project teams/task forces and is accountable for recommending global CMC regulatory strategy. Works closely with other individuals/groups within Astellas global Regulatory Affairs and with local and global stakeholders to ensure consistency and to identify options for risk discussions.
• Member of global project teams/task forces which require expert interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization. Sets direction for key operations and new initiatives in collaboration with local and global stakeholders
• Provides CMC regulatory expertise for New Product Planning and Licensing due diligence activities.
• Manages the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements. In collaboration with local and global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global health authorities. Prepares and reviews summary tables of data from research and manufacturing reports, without direct supervision. Defines and implements regulatory strategies and priorities for; global registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control issues in collaboration with local and global stakeholders.
• Oversees global submissions and ensures that the compilation and transmission of submissions are within the defined time schedules and meet established standards and SOPs. Reviews global regulatory submissions for consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and registration filings.
• Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for chemistry, manufacturing and controls aspects.
• Provides regulatory guidance for compendial issues, JP/EP/USP and other national compendial monographs, and monograph preparation

Required Qualifications:

• BS in Biology or equivalent degree
• 10 years industry experience; pharmaceutical companies, CRO or academic with at least 6 years experience directly in Regulatory Affairs or in CMC regulatory or role with CMC regulatory submission responsibilities.
• Experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope.
• Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products is required.
• Advanced interpersonal written and oral communication skills, as well as advanced collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast-paced environment
• Ability to manage complex projects by exercising independent decision making and analytical thinking skills
• Knowledge/experience of EU, US and/or Japan regulations, guidelines and regulatory processes for NCEs, NBEs and product life cycle maintenance
• Ability to work in cross-functional and international environment; detail- and goal-oriented, quality conscientious, and customer-focused
• Ability to write and speak English fluently
• Demonstrated track record for successful Health Authority interactions related to CMC submissions.

Preferred Qualifications:

• Gene and Cell Therapy Experience Preferred (US, EU, JP)
• MS. or Ph.D in Chemistry/Biochemistry/Engineering, PharmD or equivalent degree with 6 years experience in CMC regulatory or role with CMC regulatory submission responsibilities
• Experience managing direct report is preferred

Location and Working Environment

This position is based in Westborough, MA. Remote work from anywhere in the US is available.

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.

This position is a global role with strong interaction with various disciplines and international stakeholders

• Highly matrixed environment requiring cross-regional coordination.
• Frequent interaction with senior leadership and governance bodies.
• Collaboration across EU, US, and Japan time zones.

Salary Range

$144,060 - $205,800 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)

Benefits:

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Company fleet vehicle for eligible positions
• Referral bonus program

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