The Manager, Regulatory & Clinical Affairs, plays a key role in ensuring regulatory compliance and labeling accuracy across all QuVa sites. This role oversees third party submissions, supports product formulation, conducts therapeutic equivalency reviews, and manages the development of CSP and Bulk artwork. The Manager also coordinates investigations, supports customer onboarding through ASHP tool assessments, and partners with cross-functional teams to align regulatory and clinical activities with business goals, all while maintaining compliance with FDA 503B requirements.
What the Manager, Regulatory & Clinical Affairs Does Each Day:- Oversee third party submissions (First Data Bank, Medi-Span, Cerner Multum, IBM/Redbook)
- Review and approve the accuracy of label claims for new artwork creation and bulk labels to ensure alignment with FDA 503B labeling requirements
- Spearhead the development and regulatory oversight of CSP and bulk artwork across all QuVa sites to ensure consistency and compliance.
- Review and approve therapeutic equivalency for product conversion
- Drive team improvements by resolving inefficiencies and implementing sustainable, safety focused solutions
- Manage change requests for BUD extension in collaboration with Quality Control
- Review and approve REMS
- Support staff with pharmaceutical calculations, product formulations, and related labeling inquiries
- Serve as a backup for Master Batch Records, Bill of Materials as needed
- Strengthen team performance through workforce planning, development, and leadership growth initiatives
- Work with cross-functional teams to align Regulatory & Clinical Affairs activities with overall business objectives
- Coordinate investigations of deviations and CAPAs owned by Pharmacy Services
- Manage ASHP tool assessment questionnaires and support customer onboarding
- Collaborate on vendor contract questionnaires for new customers and renewals
- Evaluate Finished Drug Product to ensure label compatibility and compliance
- Assist with FDA inspections related to labeling and ensure compliance with 503B requirements
- Create and update SOPs as applicable
- Maintain a safe and clean working environment by complying with procedures, rules, and regulations
Our Most Successful Manager, Clinical & Regulatory Affairs has / is:- Sense of urgency, accountability and resourcefulness (e.g., work in changing environment)
- Self-starter, independent learner
- Communication: Promotes active listening with team members; Contributes appropriately to conversations; Strong verbal and written communication skills with the ability to work effectively with other departments within the organization and with people at all levels of the organization
- Problem Solving: Understands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transform
- Efficiency with MS Office suite
Minimum Requirements for this Role:- Licensed pharmacist
- 4+ years in an FDA cGMP environment
- Quality or Pharmacy experience
- Knowledgeable in FDA cGMP compliance
- Must have hospital pharmacy experience
Benefits of Working at Quva:- Comprehensive health and wellness benefits including medical, dental and vision
- 401k retirement program with company match
- 22 paid days off plus 8 paid holidays per year
- National, industry-leading high growth company with future career advancement opportunities
