Experienced- Regulatory Affairs Manager - CMC
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Description:
Summarized Purpose:
Provides technical/project leadership over several regions or globally, providing innovative solutions including regulatory expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient, and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as key liaison with internal and external clients in the provision and marketing of these services. Typically works on projects with high complexity.
Essential Functions:
• 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.
Skills:
Regulatory, cmc, authoring documents, BLA
Top Skills Details:
Regulatory,cmc,authoring documents,BLA
Additional Skills & Qualifications:
Knowledge, Skills and Abilities:
• Proven ability to fully author common technical document (CTD) Module 3 Quality sections and Module 2.3 Quality Overall Summary (QOS) for investigational products, clinical phases 1-3.
• Demonstrated track record of authoring IMPD, IND Module 3 and 2.3 for biologics and/or small molecules. Authoring to the level of commercial MAA, BLA, NDA is a distinct advantage
• Ability to author EMA, FDA (other) scientific meeting packages: EMA scientific advice, FDA pre-IND, EOP2 etc.
• Outstanding English language (written and oral) communication skills as well as local language where applicable
Experience Level:
Expert Level
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.