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Miles
Km80.5

Director, Regulatory Affairs

A.P. Pharma, Inc.

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Location: Redwood City, CA Posted Date: 4/23/2013 Position Type: Full time Job Code: 1311 Required Education: Bachelors Degree Areas of Expertise Desired: Process Development
Regulatory Affairs

Description

JOB DESCRIPTION:
Responsible for all aspects of regulatory affairs strategy and submissions covering the development phases from preclinical,clinical, and registration to post approval requirements. Responsible for development and implementation of regulatory procedures and systems to accomplish corporate objectives, including setting priorities and allocating resources. Serves as the primary company contact with the U.S. Food and Drug Administration. Implements the procedures and processes for post market activities to ensure products meet regulatory requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Prepares and/or manages submissions that are technically complex and/or require extensive interaction with departments outside the Regulatory Affairs (e.g., INDs, CTAs, NDAs, and CTDs).
• Actively participates on project teams and provides advice and direction including identifying and assessing regulatory risks regarding regulatory requirements and strategies.
• Interacts directly with US regulatory agencies (state and federal), including the FDA, FDB, and corresponding international agencies.
• Develops/oversees development of Regulatory department SOPs
• Responsible for establishing standards for compliance of regulatory submissions with health authority laws, regulations and guidance documents.
• Responsible for evaluating the regulatory standards and procedures for the management of regulatory filings to maintain compliance with international and domestic record retention requirements and corporate policies.
• Ability to support the product development team to assess whether technical arguments are presented clearly and conclusions are supported by data.
• Utilizing internal and external courses and workshops, maintains knowledge of the laws, regulations and guidelines governing drug development and approval.
• Manages and/or reviews corporate publications, labeling, advertising and promotional materials (including materials related to development and post-marketing activities).
• Manages and reviews safety reports and submissions.
• May be responsible for conducting performance reviews and providing feedback and coaching to direct reports.

Requirements

• Bachelor’s/Master’s degree in scientific, health care or related field or equivalent.  A minimum of 10 years of pharmaceutical industry experience, or equivalent, with 5-10 years of regulatory experience required.
• A minimum of 5 years previous management experience is required. Must demonstrate the ability to work through others.
• Must demonstrate understanding of pharmaceutical development and knowledge of FDA requirements. Direct experience with FDA required and international experience preferred. Post marketing FDA experience required working knowledge of scientific principles.
• Highly organized with attention to detail. Strong verbal and written communication skills are required, as well as excellent scientific writing,
presentation and documentation skills.
• A leadership role in project teams with approximately 40% of time in meetings.
• High level expertise in MS Word to create documents, work within templates, with the ability to recognize and change errors in formatting. Has familiarity with MS Excel, Adobe Acrobat and PowerPoint applications. Working knowledge of electronic publishing/file management system.
• Moderate travel (approximately 10 - 20%)
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