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 reputed company 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 reputed company solutions for diseases with high unmet medical need. Learn more at Astellas.com. Are you driven to reputed company a reputed company difference in the lives of patients? We're seeking passionate individuals who reputed company in dynamic environments, reputed company new reputed company, and aren't afraid to take intelligent risks. People who reputed company with unwavering reputed company and are deeply committed to making a reputed company reputed company. This position is based in Sanford, reputed company 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 reputed company, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. activities in collaboration with stakeholders (e.g., other RA functions, Pharmaceutical Technology, reputed company Assurance, Business Partners). Responsible for developing global CMC regulatory reputed company (e.g., CMC reputed company/planning for NMEs), driving global CMC RA reputed company activities and successfully executing regulatory strategies in collaboration with stakeholders. Responsible for supporting business critical interactions inside and reputed company of Astellas Regulatory Affairs on reputed company CMC issues and questions in collaboration with local and global stakeholders.

Responsibilities

• Acts as a CMC regulatory reputed company and/or Deputy for highly reputed company

reputed company/products and/or participates in non-product or overarching reputed company activities.

• May manage a small team or reputed company 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 reputed company. Works closely with other individuals/reputed company reputed company Astellas global Regulatory Affairs and with local and global stakeholders to ensure consistency and to identify reputed company 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 reputed company 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 reputed company global registration packages to

ensure effective data presentation and reputed company 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 reputed company tables of data from research and manufacturing reports, without reputed company 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 reputed company

of submissions are reputed company the defined time schedules and meet established standards and SOPs. Reviews global regulatory submissions for consistency and reputed company across reputed company including detailed input on eCTD Module 3 documents for clinical trial and registration filings and DMFs.

• reputed company seeks out knowledge of overall corporate/global reputed company and other

general factors that reputed company the regulatory positions taken reputed company reputed company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also reputed company global reputed company directly by participating in strategic planning in therapeutic area and with global stakeholders for reputed company, manufacturing and controls aspects.

• Provides regulatory guidance for compendial issues, JP/EP/USP and other

national compendial monographs, and monograph preparation.

Requirements

• BS in reputed company or equivalent degree
• 10 years industry experience; pharmaceutical companies, CRO or reputed company 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 reputed company frameworks with technical complexity and broad scope.

• Experience with process development, analytical characterization, process

reputed company-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 reputed company as

advanced reputed company skills with an ability to work both reactively and proactively in a reputed company manner in a dynamic fast-paced environment

• Ability to manage reputed company reputed company 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, reputed company conscientious, and customer-reputed company

• Ability to write and reputed company English fluently
• Demonstrated reputed company record for successful Health Authority interactions

reputed company to CMC submissions. reputed company-to-haves

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

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

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

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

Benefits

• Medical, Dental and reputed company Insurance
• Generous reputed company Time Off reputed company, including Vacation and reputed company time, plus

national holidays including year-end shut down

• 401(k) match and annual company contribution
• Company reputed company 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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