Associate Director, Clinical Regulatory Affairs

Associate Director, Clinical Regulatory Affairs

The Associate Director of Regulatory Affairs will support the development and implementation of regulatory strategies for pipeline programs.  The Associate Director will be responsible for the initiation and maintenance of global clinical trial applications, contribute to the development of Regulatory Affairs content for US and global regulatory submissions, interactions with FDA and other regulatory agencies worldwide, and the overall global regulatory strategy. This individual must have the experience to work independently, be highly-collaborative, creative, flexible to different ideas, and remain grounded in a dynamic fast paced environment. Of importance, is this individual’s willingness to assist others when called upon to ensure the success of the team and business objectives and strong oral and written communication skills.

This is a hybrid role - our work from home days are Monday and Friday and our in-office days are Tuesday, Wednesday and Thursday.

Essential Functions and Job Responsibilities:

• Contribute to development and execution of global regulatory strategies for programs in development.
• Support management, drafting and submission of company’s first NDA.
• Plan, author and review high quality regulatory submissions (INDs, CTAs, Health Authority Meeting Packages).  Manage preparation and submission including the development of timelines.
• Interface with cross-functional teams outside consultants to obtain timely regulatory deliverables and ensure regulatory compliance.
• Advise other departments on Health Authority requirements for product development and regulatory submissions.
• Participate in negotiations with Regulatory Agencies to resolve issues and prepare and submit responses to questions.  Prepare for Health Authority meetings including briefing documents, etc.
• Maintains knowledge of regulatory environment, regulations, and guidelines.
• Develop internal regulatory procedures and practices.
• Complete other responsibilities as assigned and agreed upon.

Minimum Qualifications:

• Bachelor’s degree or equivalent work experience in Regulatory Affairs or related discipline required.  Advanced degree (MS, PharmD, or PhD preferred).
• At least eight years of experience in Regulatory Affairs for pharmaceutical drugs.
• Experience with rare/orphan drugs preferred but not required. 
• Experience in preparation (authoring and review) of documents for global Health Authority submissions including but not limited to INDs, IND Amendments, CTA submissions, Health Authority Meeting packages, and Marketing Authorization Applications (NDAs, BLAs or MAAs).
• Experience interacting with Health Authorities including meeting preparation.
• Knowledgeable in ICH, EMA, and FDA guidelines.  Understanding of GxP systems and Quality principles.
• Ex-US and/or global regulatory experience highly desired.
• Ability to research global regulatory guidance (nonclinical and clinical) precedence to assist in the development and execution of global regulatory strategies.
• Knowledge of eCTD structure, components and basic regulatory operations which support in-house regulatory submissions.
• Excellent writing, oral and organizational skills, time management and ability to generate clear, concise documents.
• Proficiency in using Microsoft Word, Excel and PowerPoint.
• Continuous quality improvement, and attention to detail.
• Collaborative, strong team player, self-motivated team player who is comfortable in wearing many hats.

The anticipated salary range for candidates who will work in Newark, California is $170,000 - $195,000.  The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc.  CymaBay is a multi-state employer, and this salary range may not reflect positions that work in other states.

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