Regulatory Affairs Manager

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Job description

Overview:
Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We're investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you're curious, motivated by helping others, and driven by integrity, we invite you to apply.

The Regulatory Affairs Manager at Cook Myosite Inc. will manage all regulatory affairs activities, and provide direct support and expertise to the regulatory administration of developmental and commercial stage regenerative medicine products.

Responsibilities:
• Manage the regulatory and administrative requirements of projects/products, including major, complex applications submitted to regulatory agencies.
• Execute tactical objectives and functional plans within Regulatory Affairs Department.
• Assist in devising product approval pathway strategies within the global regulatory landscape.
• Ensure accurate preparation and quality control of documents for regulatory submissions (e.g. INDs, IMPDs, global investigational applications, clinical study reports, protocols, investigator's brochures, etc.).
• Ensure regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements.
• Ensure the maintenance of a centralized archive of all local regulatory files and chronological indexes, and compliance of regulatory files.
• Submit and maintain annual reports and post-approval supplements for products, as required.
• Maintain schedule of, and file, post-approval documentation.
• Interface directly with health authorities and personnel, including scientific reviewers, administrative staff, and management to facilitate the review and approval of regulatory applications.
• Review documentation from departments outside of Regulatory Affairs for regulatory impact, and assess proposed changes to documentation to ensure consistency with applicable regulatory requirements and need for communication to regulatory authorities.
• Provide interpretive analyses of complex regulatory guidance documents, regulation, or directives that impact products and operations.
• Interface directly with health authorities and personnel, including scientific reviewers, administrative staff, and management to facilitate the review and approval of regulatory applications.
• Plan and conduct formal meetings and teleconferences with health authorities as needed.

Qualifications:
• Undergraduate degree in life sciences, biomedical, engineering or regulatory science; or direct, relevant industry experience to provide a comparable background is required.

• Minimum of 3 years' within regulatory management role in Biotechnology or Biopharmaceutical industry is preferred
• Experience interacting with both domestic and global regulatory agencies (developmental and commercial stages) is preferred
• Knowledge of industry quality management tools, trends, practices, standards, and quality system interaction is preferred

• Advanced degree in life sciences, biomedical, engineering or regulatory science is preferred
• 5+ years' regulatory management experience in Biotechnology or Biopharmaceutical industry is preferred
• BLA and electronic regulatory submission preparation is preferred
• Regulatory Affairs Certification is preferred

• Understands the departmental budget, is aware of the impact of related expenses on the budget, and manages accordingly to ensure budget is not exceeded.
• Primarily responsible for departmental decisions and output.
• Effectively delegates and follows up on completion of work.
• Regularly and consistently provides status reports on all active projects and initiatives to appropriate senior managers and/or directors.
• Enforces and exemplifies company policies.
• Ability to present complex information in a clear and comprehensive manner.
• Is an effective communicator with internal and external stakeholders. Conveys clear expectations, actively listens to input and responds to feedback appropriately and in a timely manner.
• Is the departmental/functional area technical expert.
• Makes day to day decisions on activities related to quality, operations and the business.

• Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in Outlook
• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing

Physical Requirements:

• Setting: Office Setting (with travel): General office, warehouse and laboratory setting

• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.

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