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$180,000.00/yr - $220,000.00/yr Job Description – AD/Dir Regulatory Affairs Reports To:

SR Director- Regulatory Affairs. Prepare and review various modules of ANDAs, and responses to FDA queries. Devise strategy and review Meeting Packages and Proprietary Name requests with limited supervision for ANDA’s. Hands-on work experience on eCTD modules 1, 2, 3 and 5 is required. Proven ability to manage competing priorities and multiple filings in a dynamic environment is required. In-depth knowledge and experience of regulatory CMC documents review, and approval is required. Provide regulatory guidance to cross functional teams on product development, manufacturing, testing and commercialization of various complex drug products and dosage forms. Stay current and proactively implement new regulations published by the US FDA Establish and maintain effective internal and cross-functional team communications i.e. provide regular feedback and communicate work challenges/issues and successes. Maintenance of Electronic Submissions Gateway account and eCTD software eCTD compilation experience is preferred. Any other work assigned by the supervisor. Requirements and Qualifications: Bachelor’s degree with 8 plus years’ experience in regulatory strategy and filing of ANDA’s, in a pharmaceutical Industry. Hands on experience of using any e-CTD build software. Ability to multi-task in a fast-paced environment with minimal supervision. Ability to work flexibly, organize own workload and effectively manage competing priorities. Excellent attention to detail and accuracy maintaining consistently high-quality standards. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Willingness to learn new skills and flexibility to support business needs Apply knowledge and expertise, to contribute to and provide solutions to process improvements. Seniority level

Seniority level Director Employment type

Employment type Full-time Job function

Job function Research Industries Pharmaceutical Manufacturing and Biotechnology Research Referrals increase your chances of interviewing at Clinical Dynamix by 2x Get notified about new Regulatory Affairs Specialist jobs in

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