Associate Director Regulatory Affairs CMC - (Job Number: 0804908)

Associate Director Regulatory Affairs CMC - (Job Number: 0804908) DescriptionMcNeil Consumer Healthcare, a division of Johnson & Johnson group of consumer companies, markets over the counter (OTC) products. The company's OTC products include complete lines of household name brands like Tylenol , Motrin , Imodium , Benadryl , Sudafed , Rolaids , St. Joseph Aspirin and Zyrtec . Other name brands, marketed through the joint venture with Merck include Pepcid , Mylanta and Mylicon . The associate director, CMC has responsibility for the technical regulatory compliance of McNeil Consumer Healthcare (both NDA and non-NDA) products. The scope includes strong regulatory leadership in developing the optimal strategy for the business in evaluating the impact of changes to the chemistry, manufacturing and controls sections for all approved products and development projects, critically assessing CMC information for in-licensing candidates, preparing registration documents for submission to the U.S. FDA and compiling dossiers for support to relevant international markets. This function works with R&D, project management, manufacturing and quality assurance to ensure that the production processes are in compliance with the approved applications and strives to build strong working relationships with internal colleagues as well as with the FDA. Essential Functions are as follows: Participate as a major contributor on the regulatory management team to assure that CMC department goals and organizational objectives are achieved. Formulate and implement regulatory strategies and plans for major CMC submissions. Provide oversight and assist direct reports and staff in the management, timely presentation and submission of CMC sections of original INDs, NDAs and post-approval submissions. Be a leader in the development of the company's regulatory processes as they relate to CMC in order to increase departmental efficiency; while achieving consistency and standardization of working practices. Maintain excellent proactive relationships with all key customers and regulatory agencies; strong interpersonal, relationship building skills are essential. Provide sound regulatory guidance to multi-disciplinary project teams, as required. Recruit, develop, manage and mentor regulatory affairs professionals. Identify regulatory requirements for consumer products. Remain current in all appropriate regulations (and emerging trends) as well as participate in appropriate continuing education. The successful candidate will have: At least a Bachelors degree in relevant health-related scientific discipline, a Masters in Chemistry or other advanced degree a plus. A minimum of 7 years of pharmaceutical, medical device, or consumer industry experience, preferably in OTC drugs is required. At least 5 years of management experience in regulatory affairs-CMC including 3 years experience in defining regulatory requirements and preparing CMC submissions. Demonstrated ability in developing and implementing sound regulatory plans and strategies to facilitate efficient and competitive drug development. Successful track record of building strong partnerships with other organizations includes other areas of R&D, project management, manufacturing, supply chain, quality assurance and senior management. Comprehensive knowledge of the pharmaceutical and consumer product development process, analytical methods, regulations and guidelines, in particular, CMC. Demonstrated experience negotiating product approvals with FDA and detailed understanding of the current regulatory review process. Demonstrated project management and strategic planning skills. Demonstrated ability to meet challenging timelines while maintaining high submission quality standards. Proficient in the use of information technology including MS Office Software Packages, Documentum and internet, for word-processing, spreadsheet analysis, database analysis, research, etc. Excellent communication, organizational and problem-solving skills are a must. Apply Now