The Director, Regulatory Affairs is responsible for providing regulatory support and guidance to clients, project teams and regulatory staff in the preparing and/or submitting to FDA and/or European agencies for approval(s). Manage process from development of regulatory strategies thru to approval. Ensure compliance with all U.S. and international regulatory requirements pertaining to product approval.
Recruit retain and develop regulatory staff to meet organizational needs.
- Works with global functional leaders and external partnerships to support and drive processes and task delivery.
- Serves as leader within the CRO clinical operations matrix structure in support of global organizational needs and assist in the evolution of a global structure as the company grows.
- Assist and/or lead process/system improvement initiatives across operational unit and in alignment with the CRO to deliver efficiencies and benefits to customers.
- Support innovative solutions through the implementation of change management programs to ensure internal/external adoption and increased sales for continued growth.
- Ensure compliance with regulations and industry quality standards and assurance of audit readiness; includes the development of suitable company SOPs and compliance with FDA, EMEA, country specific and ICH-GCP guidelines and representation during audits and inspections.
- Anticipate emerging issues and develop solutions to them and address risks to delivery with a focus upon mitigation planning.
Global Operational Management
- Effectively and routinely communicate critical updates and changes within industry guidance, trends, and department performance,
- Monitor regulations and guidances plus industry and CRO performance trends and proactively deploy solution-based discussions and outcomes
- Manage timelines in cooperation with project management, SMEs and Regulatory Operations (Reg Ops) to ensure on-time regulatory submissions
- Support tracking of CMC regulatory commitments for INDs/IMPDs, CTAs, BLAs/MAAs and ethics submissions
- Providing CMC related guidances as needed to clients
- Manages activities to compile and organize data and documentation for NDAs, BLAs, MAAs, INDs, CTAs, associated supplements, amendments, variations, annual reports/notifications, expedited safety reports, and certificates of pharmaceutical product
- Attends and manages activities related to FDA and European Agencies-Sponsor meetings
- Reviews advertising/promotional materials for prescription drugs and biologics to ensure compliance with regulatory requirements
- Lead and drive all CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products
- Ability to fit into a dynamic group and to communicate/report information in time, depending on the level of importance
Resourcing and Line Management
- Acknowledge employee/project successes
- Trains and coaches’ regulatory staff on SOPs, regulations and guidelines
- Responsible for compensation planning and talent review for direct reports.
- Lead the selection and recruitment of suitable and qualified staff.
- Support the assessment, revision, and improvement training processes and requirements to meet changing needs.
- Integrate new team members (team or contractor) and ensure that training on SOPs and tools has been completed in a timely manner.
- Performance management including:
- non-compliance related documentation and discussions with direct reports
- Ability to detect areas for improvement and support teams in their evolution
- Provide guidance and mentoring to direct reports.
- Support/conduct performance appraisals; coach and develop staff for further advancement or enhanced skill development.
- Escalate issues related to workload, availability, performance, accessibility, etc to the applicable department Director/Head of Department, as applicable.
- Align with local and/or hierarchical management as applicable
Customer Partnerships and Project Delivery
- May be asked to support proposal writing, strategy alignment and coaching staff in bid defence practices, as needed.
- Interact with other departments to ensure high quality and execution of deliverables on-time and within budget.
- Review project budgets, potential overruns, and implement cost effective solutions.
- Use effective communication skills and effective working relationships to ensure consistent quality of work.
The above job description in no way states or implies these duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.
The Company reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company.
Essential Work Experience, Qualifications and Knowledge:
- Bachelor's or Master's degree in life sciences, or equivalent
- Minimum of 10 years global drug development experience with deep clinical research and regulatory experience in the Pharmaceutical/Biotech and CRO industries
- Knowledge of ICH GCP guidelines and industry standards of quality
- Experience in the preparation for regulatory agency meetings (e.g., Type C, Pre-NDA/MAA/NDS)
- Lead the coordination, preparation and timely submission of regulatory documents (e.g., INDs, MAAs, NDAs)
- Problem solving capabilities with strong attention to detail
- Relationship building skills and strong interpersonal presence
Desirable Work Experience, Qualifications and Knowledge:
- Clinical research experience in numerous therapeutic and/or functional areas
- Proven functional and change management experience within the Pharmaceutical/Biotech and CRO
- Ability to prioritise multiple tasks and follow to completion with industry expertise
- Strong motivational skills and understanding of customer service
Planning and Organisational Skills:
- Good interpersonal and communication skills and the ability to operate effectively in a global working environment
- Good organizational/time management skills
- The ability to work calmly under pressure and meet agreed deadlines
- Ability to work independently
- A transparent, precise approach
- Team player
- The ability to work effectively and efficiently with internal partners in Cmed
Communication and Teamwork:
- Excellent written and verbal communication skills
- The ability to make effective presentations
- Demonstrated ability to manage and lead teams
- Demonstrated ability to mobilize and motivate teams to ensure delivery in excellence
- Demonstrated ability to manage staff, providing guidance and overall professional development
- An ability to delegate tasks appropriately
- Approaches work with a professional, positive, and enthusiastic attitude
- Experience in personnel, financial and operational management
- Office Automation: Includes, but is not limited to Word, Power Point, Teams, OneNote, Adobe Acrobat Professional
- Excel: managing formulas and advanced features
- CRF/RDC Tools
- CTMS Tools