Manager Regulatory Affairs - CMC

Work Schedule

Environmental Conditions

Job Description

Responsibilities

• Authoring and preparation of CMC packages for CMC postapproval lifecycle variation submissions, annual reports, and renewals including responses to HA requests.
• Perform global change control assessments
• Confirm CMC requirements for submission e.g. variation, renewal, tender, etc.
• Align with clients (define information flow) on technical information to be provided and timelines
• Provide packages for internal client review and update these as needed
• 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 senior review and advice to prepare regional 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 for key client projects of moderate to high 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 regulatory SOPs and WPDs.
• Participates in launch meetings, review meetings and project team meetings.

General required skills and qualification

Education:

University degree in life sciences or related health sciences (BS/BA/MS or equivalent), a degree in Regulatory Affairs is advantageous.

Experience:

• Minimum of 5 years’ experience in the biotech or pharmaceutical industry, with at least 5 years in Regulatory Affairs CMC.
• Sound knowledge in life sciences with a focus on biological/vaccines/small molecule/gene therapy medicinal products.  Knowledge about 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 and problem solving
• 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