Description
We are seeking a Mgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM to join our team in EMEA/LATAM/Canada.
As a Mgr/Sr Regulatory CMC Consultant, you will contribute to planning for regulatory submissions in assigned region/country/project. You will be responsible for day-to-day management of project teams and projects, including line management responsibilities for staff members.
Key responsibilities include:
- Acting as a representative of the regulatory department with other departments
- Supporting business development, including generation of repeat business from existing clients and proposal development
- Developing, reviewing, and monitoring project budgets; reviewing client invoicing
- Monitoring personal utilization and utilization of direct reports
- Acting as a key point of contact for clients and regulatory authorities
- Providing regulatory advice to Company associates
- Conducting regulatory research on projects as needed
- Providing strategic and operational advice to clients
- Arranging, leading, and reporting on client and regulatory agency meetings
- Writing IND and product registration dossiers, clinical reports, and other regulatory documents
- Managing project teams and preparation of regulatory submissions for conduct of INDs, product registrations, and post-approval maintenance activities
- Acting as a resource for technical knowledge
- Participating in quality improvement efforts to increase overall operational efficiency
- Contributing to the building of regulatory systems and infrastructure needed for GRAS
- Developing reputation for the Company as industry leader in Regulatory by attending and speaking at industry events
- Developing solutions to complex problems
- Providing internal training in appropriate areas of expertise to other departments
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture