Associate Director CMC Regulatory Affairs

Work Schedule

Environmental Conditions

Job Description

• At Thermo Fisher Scientific Inc. youll 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 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. 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 clients 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