Thermo Fisher Scientific Inc is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of 13 billion USD, we have approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity™ Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management.
Post : Manager Regulatory Affairs
Job Description
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.
Candidate Profile
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 responsibility
• 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
Additional Information
Experience : 2 + year
Qualification : Bachelor's degree
Location : Bangalore, Karnataka
Industry Type : Regulatory Affairs
End Date : 30th November 2024
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