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 relatedactivities.
• 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 closelywith other individuals/groups within Astellas global Regulatory Affairs andwith local and global stakeholders to ensure consistency and to identifyoptions for risk discussions.
• Member of global project teams/task forces which require expert
interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMCcompliance within the organization. Sets direction for key operations and newinitiatives 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 againstapplicable regulatory requirements. In collaboration with local and globalstakeholders, determines the best way to present information in assignedregulatory submissions to maximize reviewability by global healthauthorities. Prepares and reviews summary tables of data from research andmanufacturing reports, without direct supervision. Defines and implementsregulatory strategies and priorities for; global registrations, supplementalsubmissions/variations, response documents to health authority questionsincluding Agency meeting planning and preparation, and global change controlissues 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 establishedstandards and SOPs. Reviews global regulatory submissions for consistency andquality across regions including detailed input on eCTD Module 3 documentsfor 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 thecompany, and with global health authorities, and incorporates this knowledgein interactions with others. Will also impact global strategy directly byparticipating in strategic planning in therapeutic area and with globalstakeholders 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 CMCregulatory 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 andproactively 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 submissionresponsibilities
• 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