Director, Regulatory Affairs

Job Type: Location Type: On-site

 

Director, US Regulatory Affairs

Join Minaris Advanced Therapies, a global leader in cell and gene therapy development, manufacturing, and testing! With state-of-the-art facilities across three continents and a team of over 1,400 industry experts, we are pioneering the future of advanced therapies. Our team has a proven track record of delivering more than 7,500 GMP batches, manufacturing two commercial cell therapies, and providing testing services for over 27 commercial products. At Minaris, you will be part of a mission-driven organization dedicated to accelerating life-saving treatments, advancing cutting-edge technologies, and transforming patient outcomes worldwide. Be a part of a company built for speed, scale, and science – where your expertise will help shape the future of healthcare.

The Director, US Regulatory Affairs, supports the contract development and manufacturing of client cell therapy products for the US market. This individual collaborates cross-functionally to support client projects, including support for submissions, coordinating pre-approval inspections, and managing compliant licensing for all facilities supplying the US market. The incumbent monitors the changes in the regulatory environment, regulations, health authority feedback, and regulatory guidelines and advises internal stakeholders and/or clients on the potential impact of these changes on products, processes, and systems. This individual also creates and maintains systems by which regulatory documentation is created, approved, submitted, and maintained.

Essential Functions and Responsibilities

• Coordinate projects and activities across regulatory support functions in Europe and Japan in order to formalize and harmonize regulatory processes, procedures, and infrastructure across the network.
• Responsible for maintaining up to date knowledge of regulatory requirements as well as industry and global health authority best practices and trends for cell therapy products in both clinical and commercial phases and communicate changes in requirements through the organization.
• Plan, coordinate, author, and/or review any submissions to FDA to ensure company requirements and relevant FDA requirements are met.
• Liaise with Project Managers and participate on global client project teams to properly plan for and/or support client submissions to regulatory agencies, including but not limited to strategies for technology transfer, process/method validation, and stability.
• Participate in due diligence activities for potential licensing opportunities and/or acquisitions.
• Manage GMP licensing for North America sites and supports global sites in obtaining appropriate licenses to market product in the US.
• Critically review complex reports and change control documentation for regulatory and risk mitigation strategies.
• Ensure compliance to Pharmacopeia through monitoring of changes and communication to sites.
• Develop relationships with Health Authorities through external engagement via professional organizations, conferences, and committees.
• Coordinate across Global Quality and across Sites to support inspection coordination in order to obtain the appropriate GMP certifications for each site.
• Work with the Global Head of Quality and Regulatory to plan for the long-term strategy and development of the Regulatory Affairs Department, including the development of client service offerings.
• Provide regulatory training to site level associates as a Subject Matter Expert.
• Partner with the Global Quality organization in order to maintain the accuracy of the Global Quality Manual and Standards.
• Participate in the review of Global Quality Manual and Standards, as well as global and/or regional SOPs as required in order to verify compliance to regulatory expectations and standards.
• Work with site Quality, MSAT, Operations, Supply chain functions and other stakeholders to ensure that product is released in accordance with the relevant Marketing Authorizations.
• Ensure that the information included in regulatory submissions/filings is aligned to site information and supports future compliance and maintenance.
• Support business needs to take on additional project responsibilities as assigned by management.
• Select and guide regulatory consultants and contractors to complete and/ or manage all assigned responsibilities in a timely manner.

Knowledge, Skills and Ability

• Excellent collaboration, agility, and adaptability
• Strong leadership skills including influencing ability, driving results, commitment and execution, working in teams and a matrixed environment
• Demonstrated history of strong decision making
• Well organized, adept at planning and working effectively within cross-disciplinary teams Excellent oral, written, and verbal communication skills are required
• Strong computer skills are required

Education and Experience

• BA/BS in the Life Sciences is required. MS or PhD in chemistry or biology and/or Regulatory Affairs is strongly preferred.
• Minimum 7-10 years in Regulatory Affairs in an FDA Regulated Industry is required
• Thorough knowledge of ICH Guidelines and FDA cGMPs and Guidelines is required. Knowledge of European and Japanese Health Authority requirements is strongly preferred
• CMC Regulatory experience in cell therapies is required Regulatory Affairs Certification preferred
• Ability to work independently with minimal supervision is required Proven interpersonal skills with face to face and remote teams

Quality Requirements

• Build Quality into all aspects of your work by maintaining compliance to all quality requirements.
• Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
• Attend all required Quality & Compliance training at the specified interval.

Working Environment

Employee will work with moderate noise level within an office or home office setting. Employee will perform tasks while experiencing numerous interruptions. Employee may travel by car and airplane to work at different locations and may occasionally be required to travel overnight. The work environment is fast paced. This position has the utmost responsibility for adherence with the rules and regulations regarding a compliant work environment relative to their actions and conduct. Off-shift, weekend and overtime duties may be required. While performing the job duties of this job, the employee is regularly required to use English written and oral communication skills.

Physical Requirements

The physical and mental demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

While performing the duties the employee is:

• Constantly required to sit, and to reach to use computers and other office equipment
• Constantly stand for extended periods of time, up to four hours/time
• Occasionally required to lift up to 40 pounds
• Constantly required to view objects at close and distant ranges with hand and eye coordination
• Frequently required to communicate with others

Special Working Conditions

Up to 10% travel, US and international, may be required.

Disclaimer

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.

Monday-Friday, Day Shift