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Job #02609

About our client Our client is a publicly traded biopharmaceutical company that is dedicated to the development and commercialization of trans-dermal therapies. The company has marketed products, an experienced management team and an empowering corporate culture that is focused on the professional development of its employees; this is a great opportunity for the right candidate! Position Location CMC Manager, Regulatory Affairs Southeast USA Salary Reports to Highly competitive package, commensurate with experience Management Responsibilities 1) Determine regulatory strategy and plan 2) Co-ordinate CMC documentation/data for submission to ANDAs, INDs and NDAs 3) Develop strategy for manufacturing changes that require filing with the FDA 4) Ensure that all CMC documentation and regulatory submissions are prepared to meet the US regulatory standards and provide information for worldwide submission under business partner direction 5) Produce approvable CMC components of regulatory dossiers with appropriate manufacturing flexibility 6) Serve as CMC advisor on regulatory issues relating to both developmental and marketed products to allow timely completion of development plans 7) Provide regulatory input on the project teams 8) Work with QA and manufacturing to ensure that all regulatory requirements are met 9) Ensure that CMC regulations are communicated through the company policies and procedures 10) Create and revise SOPs governing regulatory CMC activities 11) Review and approve all changes to the manufacturing processes to ensure compliance with FDA guidelines 12) Prepare regulatory specifications for incoming materials, process intermediates and finished products with adequate control and flexibility for the life cycle of the product Requirements 1) BS in Chemistry or a related science (Biochemistry, Biology, Pharmacy, Microbiology) 2) Minimum 8 – 10 years of professional experience within the pharmaceutical environment (with at least 5 years of regulatory experience with a focus on drug CMC and 2 years of management experience) 3) Experience in providing CMC support for worldwide application and change control documentation 4) Knowledge of CFR, ICH and FDA regulations and guidance preferred 5) Ability to act independently and to take initiatives 6) Ability to manage complex projects and interact with the FDA 7) Good project management skills