Director of Regulatory Affairs Apply
About the job
The Director of Regulatory Affairs is responsible for overseeing all regulatory affairs and regulatory compliance matters, 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: 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 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 DA, MHRA, EMA, and other Regulatory agencies.
- Thorough understanding of CDMOs and scientific & clinical data/terminology, & the drug development process.
- 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.
- 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 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
- 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 the 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 for personnel.
- Work 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.
- Demonstrable 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, mentorand ship, 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 and fully leverage the 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 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.
- 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.
