Astellas Pharma Senior Manager Regulatory Affairs CMC, Cell/Gene Therapy in Westborough, Massachusetts
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Westborough, Massachusetts. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
This position plays a key role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions.
This position is responsible for development and successful execution of CMC regulatory strategy (e.g., CMC strategy/planning for NMEs and NBEs) in close collaboration with Global Regulatory Lead, and writing of CMC documents (e.g., CMC modules, IND/IMPD CMC documentation), for assigned products.
This position can act as the subject matter expert (SME) for Regulatory CMC and works in close collaboration with stakeholders (e.g., Pharmaceutical Technology including PPM and Manufacturing, Quality Assurance, Business Partners).
Essential Job Responsibilities:
Independently acts as CMC regulatory lead or Deputy for complex projects/products and/or participates in non-product or overarching related activities.
Prepares and reviews with minimal supervision, CMC documentation of e-CTD Quality modules, IND/CTA/IB and briefing documents for Health Authority (HA) consultation meeting for assigned products.
Acts as CMC regulatory expert by global project and product 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 regional 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/PMDA/ICH/Global regulations to ensure CMC compliance within the organization.
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 and regional registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control processes and related compliance issues in collaboration with local, regional and global stakeholders.
Oversees submissions and ensures that the compilation and transmission of submissions are within the defined time schedules and meet established standards and SOPs. Reviews 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 of Ph.Eur., USP and JP and monograph preparation.
This position interacts with management level on routine and serious matters; internally and externally to influence policy and strategy; with development partners, including negotiations on controversial areas. SME role in health authority meetings. Works on complex and diverse problems with suggestion as SME that has functional or corporate impact.
Reports to Associate Director, Director or Senior Director, Regulatory Affairs CMC.
BS in Chemistry/Pharmaceutics or equivalent degree
8+ years industry experience; pharma, CRO or academic with at least 3 years' experience
directly in Regulatory Affairs or in CMC regulatory or role with CMC regulatory submission responsibilities in CMC related laboratories.
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.
Demonstrated track record for successful interactions with (global) health authorities related to CMC submissions.
Effective writing skills with the ability to meet regulatory requirements and standards
Ability to understand regulatory environment and apply concepts to perform job function
Advanced academic degree (Ph.D. or Pharm.D.), with relevant experience (5+ years) in product development in the manufacturing or regulatory field.
Advanced, interpersonal written and oral communication skills; 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/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 adhere to strict project timelines; strong team player; good judgment and problem-solving skills, with ability to identify, analyze, and resolve problems in a timely manner.
Fluent written and spoken English is required.
An additional experience next to small molecules, such as biological, vaccines, cell therapy or (medical) devices in a regulatory environment, or vice versa, might be a preference.
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
Referral bonus program
Category Regulatory Affairs
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans