Andelyn Biosciences is an industry-leading cGMP production facility dedicated to advancing the field of gene therapy. Our mission is to use our knowledge, resources, technology, and experience in the field of translational and regulatory science, to develop new, safe, and effective long-term treatments for diseases. There is no disease too rare and no challenge too difficult as we strive to make a difference with every product and to leave hope on the minds of every patient and their family. Andelyn is primarily a full-service manufacturer of Adeno Associated Virus (AAV). We work with over 100 clients each year to manufacture AAV at development, preclinical, clinical, and commercial quality.
The Clinical Manufacturing Facility at Andelyn Biosciences is a Leading cGMP production facility dedicated to advancing the field of Gene and Cellular Therapy. Our Mission is to use our knowledge, resources, technology, and experience in the field of translational and regulatory science, in collaboration with our clients, to develop new, safe, and effective long-term treatments for diseases. There is no disease too rare and no challenge too difficult as we strive to make a difference with every product and to leave hope with every patient and family.
We are seeking a Senior Director of Compliance Regulatory Affairs - The Senior Director of Compliance and Regulatory Affairs is responsible for leading and implementing departmental process improvements, overseeing all regulatory affairs and regulatory compliance matters, regulatory intelligence, while providing strategic input on regulatory applications, clinical development plans, technical and training guidance requirements. Additionally, this individual is responsible for working with internal and external teams/clients, as well as vendors, to manage short- and long-term global regulatory activities that support the success of investigational and marketed products throughout their lifecycle, including the compilation, preparation, coordination, review, and submission to Health Authorities.
Schedule: Full-time (Benefits Eligible)
700 Children's Drive
Columbus, OH 43205
Under the guidance and direction of the Head, Quality, essential functions of the Senior Director, Compliance and Regulatory Affairs:
· Serve as point of contact with clients and internal teams for all regulatory matters relating to contractual requirements, deliverable changes, timelines, and deliverables.
· Provides strategic regulatory input and technical guidance on regulatory requirements to project teams and clients including monitoring the impact of changing regulations on submission strategies and updates.
· Monitoring the impact of changing regulations on submission strategies and updates while overseeing the publishing of regulatory submissions according to CFR, FDA, DMF, ICH guidance.
· Thorough understanding and familiarity with ICH/ GCP, current ISO 9001 and ISO 27001 standards, 21 CFR Part 11, FDA, and GCP requirements. Understanding of CDMOs and scientific & clinical data/terminology, & the drug development process.
· Demonstrates an excellent understanding of country requirements for investigational and marketing applications, i.e. INDs, NDA/BLAs, IMPDs, CTAs, DMFs, and MAAs - overseeing the planning and execution of those applications and subsequent submissions to regulatory authorities within company timelines and in accordance with regulations and guidelines.
· Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information.
· Develops and maintains SOPs, work practices, forms, and other documentation and training materials related to regulatory affairs and regulatory compliance services.
· Actively promote new business by participating in project bids and client presentations as appropriate.
· Lead the effort to determine stakeholders’ needs and ensure business value is realized.
· Demonstrate a strong understanding of standards, guidelines, and FDA regulations and takes initiative to suggest and implement process improvements and follow through to completion.
· Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client.
· Work with management and stakeholders to identify priorities, goals, and milestones.
· Identify future risks and provide solutions before the risks become a barrier to producing quality deliverables on time.
· Strong understanding of external Regulatory landscape, to develop and maintain strong external and internal stakeholder connections.
· Ensure the departmental goals are met and are in line with company goals.
· Responsible for supporting the development and execution of both short- and long-term recruitment strategies to ensure the company’s growth including providing hiring recommendations of personnel.
· Work with management in other departments to develop business initiatives and process improvements across the organization; solution-focused.
· Monitor staff projects quality, timeliness, and budgets to foresee and correct issues and assure project expectations are met.
· Gather and monitor key metrics to assess project performance
· An ability to assess situations and make and carry through difficult decisions.
· Demonstrable experience in stakeholder/ relationship management with a client-focused approach to work.
· Advanced ability to manage multiple and varied tasks across multiple projects with enthusiasm and prioritize workload with attention to detail.
· Provide leadership, mentorship, and develop personnel by maintaining a positive work environment.
· Responsible for the professional development of colleagues.
· Work with senior management in developing managers and ensuring a talented pipeline of management staff within the department.
· Schedule and facilitate stakeholder meetings to communicate project status, discuss escalated issues and ensure the project is meeting customer requirements.
· Establish operational excellence training to educate employees and promote a culture of continuous improvement.
· Mentor, develop and collaboratively work with the team to promote fully leverage team’s experience and
· Utilizes clear and concise communication to ensure the team is fully integrated across the organization.
· Utilizes business acumen and considers business impacts in planning and problem-solving.
· Limited travel may be required.
· Other duties as assigned.
Knowledge, Skills, and Abilities Required
· Graduate degree with 10 years or Bachelor’s degree with 15+ years in scientific, medical, clinical Engineering, Life sciences, or other similar technical field discipline or related field. Related or relevant work experience in pharmaceutical/biotech/CDMO industry Quality Assurance and Regulatory Affairs required.
· At least 10 years of experience in a CDMO environment and experience with Regulatory and Compliance Services.
· Excellent organizational, communication, negotiation, problem-solving, analytical, and consulting skills.
· Team management experience.
· Excellent interpersonal, verbal, and written communication skills (including experience in making presentations at conferences, meetings, training sessions).
· Experience in the development and implementation of systems and business processes.
· Operational Excellence experience. (Lean Six Sigma certification preferred).
· Effective communication and interpersonal skills.
Minimum Physical Requirements
· Sitting for extended periods Constantly (67-100%)
· Typing on a computer keyboard Constantly (67-100%)
· Working at a computer constantly (30-60%)
· Talking in-person/on phone constantly (30-60%)
· Standing/walking occasionally (0-33%)
The above list of duties is intended to describe the general nature and level of work performed by individuals assigned. It is not to be construed as an exhaustive list of duties performed by the individual, nor is it intended to limit or modify the right of any supervisor to assign, direct, and control the work of employees under his/her supervision.
Andelyn Biosciences is currently operating under Executive Order 14042 which requires that employees of federal contractors and its affiliates be vaccinated against COVID-19, with some limited exemptions under the law. As Andelyn is both an affiliate and will be a federal contractor, proof of vaccination status will be required prior to the first date of employment. Religious and medical exemptions may be considered depending upon the specific job duties and in accordance with applicable federal guidelines.