The Director, RA participates with R&D, QA, Operations, Business Units and others in the development of and leading of the implementation of Regulatory Affairs strategies. Point of contact with Regulatory Agency to expedite approval of pending applications; resolve sophisticated and complex regulatory matters, and to negotiate J&J’s position to establish submission strategies and gain agencies approval. Agencies include but are not limited to FDA, USDA, US Customs and Border Protection, etc. Provide overall management of staff, development plans, training and budget and Regulatory Affairs activities to ensure short and long term objectives are achieved in a proactive, cost and time efficient way.
Motivates and empowers team towards key deliverables. Facilitates team work and knowledge sharing by providing direction, tools, and resources.Communicates information on product/project activities to Senior Management and key internal /external stakeholders. Understands implications of the global business and develops strategies within the global context to be implemented in area of responsibility.
Actively leads as a member of task forces and committees of trade associations. Makes decisions based on risk assessments balancing business needs and the needs of consumers or the risks of being challenged by NGO’S, authorities or competitors. Independently or in partnership with other critical functions, develop and execute plans to address sensitive issues. Prioritizes high value addition initiatives over low value strategies and programs. Develops and manages relationships inside and outside the organization for effective circle of influence. May develop and manage significant budgets. Positions without direct budget responsibility have significant financial and resource impact through critical project management.
Qualifications
Minimum B.S. Chemistry, Pharmacy or related scientific field required. At least 15 years of industry experience, either in pharmaceutical CMC and/or Consumer products required. In depth knowledge of regulatory requirements for various cosmetic, drug and device dosage forms including solids, semi-solids, solutions, sterile products, etc. required. Experience across all consumer product categories preferred. Strong technical/science-based background required. Strong knowledge of GMP and regulatory compliance required. Must have good interpersonal and written skills
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