Global Regulatory Affairs, CMC, Gene Therapy (Associate Director)

About the position Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com. Are you driven to make a real difference in the lives of patients? We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact. This position is based in Sanford, North Carolina. may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose & 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. 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

• Acts as a CMC regulatory lead and/or Deputy 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 and DMFs.

• 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.

Requirements

• BS in Chemistry 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 (including oral and parenteral dosage forms) 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. Nice-to-haves

• M.S. or Ph.D in Chemistry/Biochemistry, PharmD or equivalent degree with 6

years’ experience in CMC regulatory or role with CMC regulatory submission responsibilities

• Experience managing direct report is preferred
• Previous Gene Therapy experience desired
• Additional experience beyond small molecules, such as biologics, vaccines,

cell/gene therapy or medical devices might be a preference.

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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