Senior Manager, Regulatory Affairs
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join Us as a Manager Regulatory Affairs - Make an Impact at the Forefront of Innovation
The Manager Regulatory Affairs 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.
What Youll Do:
Manage 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. Approve courses of action on salary administration hiring corrective action and terminations. Review and approve time records expense reports request for leave and overtime. Promote all aspects of Equal Employment Opportunity policy and Affirmative Action Plan. Assure department adherence to good ethical and regulatory standards.
Act as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients; manage the coordination of and ensure quality performance for key client projects. Manage and review project budgeting/ forecasting. Participate in and/or leads project meetings.
Finalize and review regulatory documents and submissions.
Identify and recognize out of scope activities in a contract in a timely manner and liaise with other departments to follow through on all aspects of contract modification.
Collaborate 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.
Provide staff with up-to-date legislation and guidance as it becomes available.
Ensure compliance with relevant organizational and departmental SOPs and WPDs
Education & Experience Requirements:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 10 years).
3 year of leadership responsibility
In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.
Knowledge Skills 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
Working Conditions and Environment:
Work is performed in an office or clinical environment with exposure to electrical office equipment.
Occasional drives to site locations. Potential occasional travel required.
Why Join Us
When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.
Apply today to help us deliver tomorrows breakthroughs.
Required Experience:
Senior Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
