Summarized Purpose: Manages a team within the department and provides innovative solutions including regulatory expertise and client interface to provide strategic regulatory intelligence and guidance for product development from preclinical through registration and product optimization.Essential Functions:
Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime. Assures department adherence to good ethical and regulatory standards.
Acts as subject matter expert in providing regulatory strategy advice and
technical expertise to internal and external clients; manages the coordination of and ensures quality performance for key client projects. Manages and reviews project budgeting/ forecasting. Participates in and/or leads project meetings.
Finalizes and reviews regulatory documents and submissions.
Identifies and recognizes out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modification.
Collaborates with business development in pricing and securing new business by making presentations to clients and developing proposal texts and budgets in collaboration with other departments.
Provides staff with up-to-date legislation and guidance as it becomes available.
Ensures compliance with relevant organizational and departmental SOPs and WPDs.
Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). 2 + year of leadership responsibilityKnowledge, Skills and Abilities:
Strong English language communication and negotiation skills, as well as local language where applicable, both oral and written
Solid understanding of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, licensing and lifecycle management
Thorough understanding of ICH and other global regulatory guidelines
In-depth knowledge of at least one of the regulatory speciality areas: preclinical, clinical, CMC, publishing, etc.
Strong understanding of budgeting and forecasting with the ability to interpret data with attention to detail and analytical and investigative skills
Capable of supervising, evaluating, and mentoring departmental personnel
Capable of delegating tasks and facilitating the completion of assignments
Capable of driving innovation in developing new ideas related to process improvements
Strong organizational, judgment, analytical, decision-making and interpersonal skills to manage complex projects in parallel and manage rapidly changing priorities Effective computer skills, including the use of Microsoft (MS) Word, MS Excel, Adobe Acrobat, etc.
Capable of independently assessing sponsor needs and working with project team members in producing compliant deliverables
Capable of independently learning new technologies
