Senior Manager 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 Leads CMC strategy authoring and preparation of postapproval variations annual reports renewals tender applications and GMP submissions including responses to HA requests
• Performs global change control assessments and provide CMC requirements for variations.
• Align with clients (define information flow) on technical information to be provided and timelines
• Oversee and provide packages for internal client review and update these as needed
• Oversee and provide finalized packages for publishing and QC published output
• Update of internal systems (RIMS Publishing eDMS) or documentation as needed
• Support requests for information from HAs or from partners
• Provides regional lead review and technical advice to prepare regional and/or global regulatory submissions and ensure high quality standards that meet or exceed client expectations local and regional requirements.
• Acts as subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and oversees key client projects of the highest complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available.
• Ensures quality performance for key/managed projects.
• Manages project budgeting/forecasting functions.
• 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 modifications.
• Collaborates with business development in pricing and securing new business by making presentations to clients and develops proposal texts and budgets in collaboration with other departments.
• Provides matrix/project leadership training and guidance to junior team members.
• Ensures compliance with relevant organizational and department SOPs and WPDs.
• Participates in launch meetings review meetings and project team meetings. May lead departmental initiatives/project teams.

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:

• 8 years regulatory experience in the pharmaceutical/health care industry. 5 years Regulatory CMC experience.
• Sound 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 CMC authoring skills and able to evaluate technical and scientific CMC information for accuracy and compliance with 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

  Benefits

  We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!

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 aflexible working culture where PPD truly value a work-life balance. Weve 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 worlds most urgent health needs submit your application wed love to hear from you!

Clinical Research Thermo Fisher Scientific

Our team of colleagues in clinical research services are atthe forefront of getting cures to market

#StartYourStory at Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.