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Title Location Type Rate Apply
Regulatory Affairs Manager  Orlando FL  Perm/Full $65,000 - $85,000

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Regulatory Affairs Manager
• Responsible for the assembly of ANDAs, INDs and NDAs and regulatory filings amendments, supplements, and international dossiers) for all products: collect and review relevant information from other departments, write the application and direct staff on assembling components of the application.
• For international dossiers, request free sale certificates, certificates of pharmaceutical product, notary certifications from the secretary of state and/or consulate.
• Review submissions to ensure that regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements; submit to management for review, revise accordingly, and ensure timely submission.
• Act as a point of contact on regulatory applications, resolve issues/ inquires/ deficiency letters and follow up to ensure submissions are acceptable for filing and/or approvable.
• Identify, contract, and manage outside consultants/ contractors for analytical method development / validation pertaining to a deficiency response to a deficiency.
• Maintain document control system of the regulatory department including maintenance of archive systems, both paper and electronic.
• Participate and support new product and/or process developments.
• Identify, contract, and manage outside consultants/contractors for deformulation studies and analytical method development/ validation resources.
• Maintain facility and product registrations, domestic and foreign.
• Identification of active pharmaceutical ingredient (API) manufacturers and suppliers. Request samples of APIs, technical package, and Establishment Inspection Reports (EIR). Submit samples to the chemistry and microbiology departments for API vendor qualification. Develop and maintain knowledge of the history, manufacture, and materials.
• Applies regulatory knowledge and experience and advises management relative to drug development program strategies to ensure acceptance and earliest possible approval of applications and filings.
• Maintain subscriptions and review technical publications, articles and abstracts to stay abreast of technical developments in the industry.

Requirements:

• Bachelor’s of Science Degree in scientific discipline required.
• Minimum of 6 years progressively increasing responsibility in Pharmaceutical Regulatory Affairs.
• Working Knowledge of FDA regulations.
• Proficiency in Microsoft Office Suite.
• Excellent interpersonal, technical writing, and oral communication skills.
• Must be highly organized. Ability to manage multiple projects and changing priorities is required, as is the technical knowledge of pharmaceutical products and processes.
• Determine task priorities and delegate responsibilities to staff, as appropriate.
• Possess an attention to detail. Must be able to read large volumes of printed material in a short period of time and be able to identify inconsistencies, incomplete and/or inaccurate information, provide corrections, and changes.