Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
At Thermo Fisher Scientific Inc., you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research, our work spans laboratory, digital, and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Responsibilities
Lead CMC postapproval lifecycle management activities for global marketed products
Oversee and review global change control strategy (for US, EU, Japan, Switzerland, Australia, China and Rest of World)
Develop, oversee and review CMC strategy and preparationfor postapproval variation submissions, strategy and annual reports ,renewals, tender applications, and site registrations, including responses to HA requests
Align with clients (define information flow) on technical information to be provided and timelines
Coordinate packages for internal client review and update these as needed
Oversee delivery of CMC packages for publishing and QC published output
Oversee and/or update of internal systems (RIMS, Trackwise, Publishing, eDMS) or documentation as needed
Support requests for information from HAs or from partners
Manages staff, which may include interviewing and selection, 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. Promotes all aspects of PPD Equal Employment Opportunity policy and Affirmative Action Plan. Assures department adherence to good ethical and regulatory standards.
Provides regulatory consulting and strategic advice to internal and external clients to determine the most appropriate regulatory and product development strategy for their products. Provides project specific strategy, technical expertise, and coordination oversight for key client's projects. Serves as the executive contact for key clients for all issues, including attendance at regulatory authority meetings and other public relation functions. Ensures quality performance for key/managed projects.
Manages project budgeting/forecasting to include creative input as to shifting of resources, allocations etc. to respond to a change in scope of personnel requirements to stay within project budget. Leads and participates in project meetings.
Ensures identification of 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 and senior management in pricing and securing new business by making presentations to clients, developing, and reviewing bid proposal texts and budgets and conducting contract negotiation through to closure with the client and BD.
Contributes to development and implementation of global/regional function/plans.
Ensures compliance with relevant organizational and department SOPs and WPDs
Creates and leads the development and implementation of processes and procedures to increase productivity and accuracy within the team. Participates in developing and implementing systems and tools to continually improve efficiency of all activities supporting and facilitating process improvements, reduction in cycle times, submission activities, metrics, and other key performance indicators.
General required skills and qualification
Education:
University degree in life sciences or related health sciences (BS/BA/MS or equivalent, PhD), a degree in Regulatory Affairs is advantageous.
Experience:
10+ years regulatory experience in the pharmaceutical/health care industry. 8+ years Regulatory CMC experience.
Strong knowledge in life sciences with a focus on biological/vaccines/complex small molecule/gene therapy medicinal products. Experience in plasma related products is an advantage.
Strong technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, Switzerland, Australia, China and Rest of World).
Strong regulatory expertise in evaluation of technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements.
Strong regulatory CMC authoring skills with proven ability to deliver high quality CMC packages which meet relevant regulatory requirements.
Strong knowledge in Good Manufacturing Practice or related areas.
Technical skills
Must be familiar and able to work with RIMS (e.g Veeva RIMS), eDMS (e.g. Veeva, Documentum) and Change Management (e.g. Trackwise) systems.
Microsoft Office skills.
Competencies:
Excellent communication, project management, planning, problem solving and presentation skills
Strong team player with a demonstrated ability to develop constructive and effective relationships with peers and management
Strong organizational and follow-up skills, as well as attention to detail
Ability to work with minimal supervision based on sound technical and analytical judgment
Flexibility to work in a global cross-cultural work environment
Fluent in English and local language
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture
,
where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our 4i Values:
Integrity – Innovation – Intensity – Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, submit your application – we'd love to hear from you!
Clinical Research | Thermo Fisher Scientific
Our team of colleagues in clinical research services are at the forefront of getting cures to market