- $177,070.00 -177,070.00/year*
125 Janelle Blvd
Our client is a financially secure, specialty pharmaceutical company that specializes in marketing prescription products and is currently establishing US operations. This is an exciting, ground floor opportunity for someone to make an impact and to build this role and its department in this growing company. Associate Director Regulatory & Compliance
Do you believe in doing the job right the first time? Do you have integrity and hold yourself to the highest standards? Are you never satisfied with good enough and want to be a valuable contributor to a collective success? If so, we want to speak with you!
As the Director of Regulatory & Compliance, you will oversee and manage regulatory matters related to the company s commercial and development product portfolio. In conjunction with that, you will be responsible for the establishment and monitoring of SOP and compliance working closely with other cross-functional development team members and outside vendors. Responsibilities: Provide the leadership on regulatory strategy and tactics contributing to the achievement of business objectives. Maintain registrations and insuring regulatory compliance for the company s commercially marketed products. Provide regulatory review/oversight/guidance for advertising and promotion; manage the medical, legal and regulatory review and submission process. Oversee documentation efforts to ensure compliance with domestic and internal regulations and standards. Participate in compliance / risk mitigation and process improvement initiatives. As Compliance Officer, oversee the regulatory process and reviews all requirements ensuring compliance with regulatory agencies/groups at Federal and State level in coordination with other functions and outside vendors. Manage activities such as audits, regulatory agency inspections, or product recalls. Coordinate and run FDA inspections at the company s US facility as required. Qualifications: A scientific degree in Pharmaceutical Science, Biological Sciences, or Chemistry disciplines is required; MS/Ph.D. degree preferred. At least 8-10 years regulatory experience in pharmaceutical, biotech or specialty pharma companies in the US market. Experience with pharmaceuticals and biologics preferred; medical device experience in addition a plus. Experience in drug development (experience with drugs and biologics expected, devices a plus). Knowledge and direct experience with the regulatory submissions process, in particular electronic submissions.
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* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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