Associate Director, Regulatory Affairs and Compliance
Compliance Insight, Inc.
Location: Cincinnati, Ohio
Type: Full Time
Required Education: 4 Year Degree
Internal Number: ADRAC1
We are currently looking for a dynamic professional and solution-oriented team player to be responsible for managing the day-to-day operations of our regulatory and compliance business and consultants.
Reporting to the President, you will:
Ensure company's compliance by updating/training company staff and consultants on current/ applicable regulations, guidelines, and current information applicable to company model
Contribute and drive directives and goals for the company
Represent the Regulatory Compliance Division of the company
Work directly with the Business Development Team to implement the strategic and tactical direction for the company
Initiate ways to improve Regulatory Compliance program
A typical day’s activities may include:
Manage potential projects and consultant projects (by providing Regulatory and Quality input, assisting with resolving issues and managing timelines and costs)
Direct self-projects awarded via client contracts utilizing Regulatory and Quality expertise (audits, training, commercial start-ups, submissions, FDA-483 resolution, etc.), resolving issues, and managing timelines and costs
Screen and conduct interviews with potential consultants and collaborators to be a part of the company’s consulting team
Cultivate new client prospects and support new client leads initiated through Business Development
Lead, participate in client/ potential client meetings
Draft, review and optimize client consulting agreements and project proposals
Represent company at conferences and industry sites for potential client work and relationship development
Build alliances with service providers
Author SOPs for Regulatory Compliance department
Attend 1-2 trainings/ webinars per year relevant to company model and career development
Maintain Regulatory Compliance database
Minimum of 15 years of experience in regulatory affairs and compliance to include regulatory submissions such as: IND, IDE, 510(k), PMA, ANDA, NDA, 513(g) meeting, De Novo, annual reports, supplements, etc. as well as electronic submissions in eCTD format.
Minimum of 5 years of progressive leadership experience.
FDA - 15 years experience.
Extensive experience in cGMP and other Regulatory and Quality compliance requirements.
Must be skilled in regulatory processes including regulatory submissions, operations, strategy, labeling, and technical writing.
Exceptional verbal, written and presentation skills: one-on-one, small group, and large group settings.
Strong customer service and project management skills.
Excellent organizational skills, including prioritization, time management, and meeting deadlines
Self-starter and able to work under pressure and deadlines.
Solutions/Results driven; get things done – whether through own efforts or delegation.
Compliance Insight is a trusted partner in the life sciences industry. We help businesses overseen by the FDA navigate the regulatory process, achieve compliance, and develop best practices for the manufacture of innovative drugs, medical devices, and biologics.