Current Opportunities

Tracking # 56 Industry Pharmaceutical Jobs Job Title CMC Manager Location Richmond, VA Salary Open Job Description A Manager of Regulatory CMC is a self-motivated strategic thinker who designs and executes CMC regulatory programs to develop medicinal agents. Such a manager provides leadership within the US Regulatory Affairs Department by actively anticipating and planning for changes in FDA CMC regulations and requirements; by troubleshooting discrepancies between products, market needs, and FDA requirements; and by making quality regulatory decisions that appropriately balance benefits and risks. The manager liaises with the FDA on behalf of the company, and coordinates regulatory submissions for human pharmaceuticals and therapeutic biologics (e.g. INDs, BLAs, NDAs, sNDAs, annual reports, and amendments). The CMC manager must ensure that all CMC regulatory requirements/commitments are met with respect to development of new products and maintenance of existing approved products. Qualifications BSC, MSc, or higher education in life sciences engineering or related field with a minimum of 7 years related experience in cGMP/FDA regulated industry and/or quality assurance experience. Extensive experience in pharmaceutical development & regulatory approval process (IND, CTA, NDA, MAA) and associated laws/regulations/guidelines. Extensive experience directing interactions & negotiations with regulatory agencies, especially FDA. Experience in biologics development would be a plus. Competencies ·In-depth knowledge of US, & ICH CMC requirements, guidelines, and application processes regarding CMC. A working knowledge of EU requirements is a bonus. ·Strong strategic & critical thinking, leadership, diplomacy, negotiation and general communication skills. ·Demonstrated ability to influence based on experience, facts & data. ·Strong organizational, time management, & project coordinating skills. ·Ability to manage precise compliance with appropriate drug product industry standards ·Proficiency in MS Office applications. ·Availability for domestic and international travel. Tasks Proactively provide timely strategic input and clearly communicate critical topics to project teams, vendors, and appropriate members of management to make quality regulatory decisions as necessary, balancing risks and benefits. Guide scientific writing for CMC sections of INDs, NDAs, supplements, and amendments, and prepare CMC regulatory documents from technical departments in R&D and Operations for submission to regulatory authorities. Maintain current understanding and expertise in relevant ICH, FDA and EU regulations. Monitor and assess the impact of global regulations, guidelines, and current regulatory environment on development programs and marketed products. Liaise with FDA through written communication and participate in Agency meetings regarding CMC regulatory issues. Facilitate regulatory communications in other markets. Ensure the implementation of CMC-related commitments made with FDA and other regulatory authorities. Ensure that the CMC information in regulatory submissions is in compliance with all applicable laws and regulations. Create, trouble shoot, revise, and/or manage robust procedures as needed to: ·Prepare CMC documentation for US, EU, and global filings from initial development through marketing authorisation and post-approval period, and respond to regulatory authority questions. ·Comply with CMC regulatory document standards and standards for electronic submissions. ·Review CMC documentation and submissions, and evaluate conformance with the regulatory requirements. ·Provide proper pre- and post-approval CMC change control. Establish and maintain sound working relationships with partners and customers as a single point of regulatory contact regarding CMC-related concerns. Evaluate potential licensing compounds and provide with CMC regulatory assessment. Supervise, coach, and develop the skills of junior staff performing CMC activities. Assist in other regulatory activities as required. Relocation Package Yes Interview Expenses Yes Benefits Package Yes