Director of Regulatory Affairs

It is an exciting time to join us!

The Director of Regulatory Affairs is responsible for overseeing all regulatory affairs and regulatory compliance matters, development of CMC strategy, and regulatory intelligence, while providing strategic input on regulatory applications, clinical development plans, and 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)

Location: Andelyn Corporate Center

1180 Arthur E. Adams Dr.

Columbus, Ohio 43221

Principal Duties and Responsibilities

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.
Develops CMC Strategy and advises clients/project teams on CMC matters.
Monitoring the impact of changing regulations on submission strategies and updates while overseeing the publishing of regulatory submissions according to FDA, MHRA, EMA, and other Regulatory agencies.

Demonstrates an exceptional understanding of country requirements for investigational and marketing applications, i.e., INDs, NDA/BLAs, IMPDs, CTAs, DM, Fs, and MAAs - overseeing the planning and execution of those applications and subsequent submissions to regulatory authorities within the company timelines, regulations and guidelines.
Demonstrates thoughtful 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 promotes 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.
Demonstrates a strong understanding of standards, guidelines, and regulations, and takes initiative to suggest and implement process improvements and follow through to completion.
Demonstrates thoughtful leadership with customers by developing and presenting to clients the 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 promotes new business by participating in project bids and client presentations as appropriate.
Leads the effort to determine stakeholders' needs and ensures business value is realized.
Demonstrates a strong understanding of standards, guidelines, and 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.

Participate in regulatory inspections and client audits.
Assists in the preparation of the response to regulatory inspections and client audits.
Works with management and stakeholders to identify priorities, goals, and milestones.
Identifies future risks and provides solutions before the risks become a barrier to producing quality deliverables on time.
Strong understanding of the external Regulatory landscape, to develop and maintain strong external and internal stakeholder connections.
Ensures 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 for personnel.
Works with management in other departments to develop business initiatives and process improvements across the organization; solution focused.
Gather and monitor key metrics to assess project performance.
An ability to assess situations and make and carry through complex decisions.
Demonstrates experience in 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 develops personnel by maintaining a positive work environment.
Responsible for the professional development of colleagues.
Works with senior management in developing managers and ensuring a talented pipeline of management staff within the department.
Schedules and facilitates 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 and fully leverage the team’s experience.
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 Life sciences, or other similar technical field discipline or related field. Related or relevant work experience in pharmaceutical/biotech/industry Quality Assurance and Regulatory Affairs is required.
Excellent organizational, communication, negotiation, problem-solving, analytical, and consulting skills.
Thorough understanding of scientific & clinical data/terminology. & the drug development process is required.
Strong understanding of CMC requirements for biologics/gene therapy products is required.

Team management experience.
Excellent interpersonal, verbal, and written communication skills (including experience in making presentations at conferences, meetings, and training sessions).
Experience in the development and implementation of systems and business processes.
Operational Excellence experience.
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 and minimum physical requirements is intended to describe the general nature and level of work performed by individuals assigned to this classification 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 committed to a diverse and inclusive workplace. Andelyn is an equal opportunity employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or another legally protected status.

Andelyn may require proof of COVID-19 vaccination prior to your first date of employment depending on whether your role would require performing under federal contracts on behalf of Andelyn. If required and in accordance with applicable federal guidelines, either proof of completion of an approved vaccine series will be required upon hire, or a religious and medical exemption may be considered depending upon the specific job duties.