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Director, Clinical Regulatory Affairs

CymaBay Therapeutics

Newark, CA | Full Time

$199k-264k (estimate)

4 Months Ago

Director, Clinical Regulatory Affairs

$199k-264k (estimate)

Full Time | Scientific Services 4 Months Ago

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CymaBay Therapeutics is Hiring a Director, Clinical Regulatory Affairs Near Newark, CA

Summary:The Director of Regulatory Affairs will support the development and implementation of regulatory strategies for pipeline programs. The Director will provide strategic and operational leadership in 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. The Director will work with functional areas and project teams to support product teams to support product development and approval. This role requires strong knowledge and interpretation of global rules, regulations, and guidance governing drugs in all phases of development. This individual must have extensive experience in drug development, developing regulatory strategies, managing regulatory submissions and marketing applications in eCTD format. In addition, this individual must be able 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. The Director of Regulatory Affairs will also recruit, retain, and develop regulatory staff to meet organizational needs. The Director will be onsite in Newark, CA typically 3 days per week.Essential Functions and Job Responsibilities:

Work with Vice President to devise regulatory strategies to ensure rapid and timely approval of products.
Develop global regulatory plans to facilitate the progress of programs in all phases of development.
Identify risk mitigation strategies and influence project teams to maximize the likelihood of regulatory success.
Support efficient conduct of development programs, while maintaining compliance with ICH requirements, regional requirements, and company procedures.
Managing regulatory documents and submissions supporting IND/CTA and marketing applications.
In collaboration with cross-functional teams and/or outside consultants obtain timely regulatory deliverables and ensure regulatory compliance.
Advise other departments on Health Authority requirements for product development and regulatory submissions.
Lead planning and preparation of Regulatory Agency meetings, working closely with SMEs. Deliverables include core content for briefing documents, presentations, and strategy documents.
Expand knowledge base of laws, regulations, and guidelines governing the development, licensure, and marketing of drugs.
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.
Proven track record of managing critical projects as part of an interdisciplinary team.
Proven track record of representing the department in project teams, committees and external meetings.
Prior experience managing regulatory submission to deadlines.
Experience with rare/orphan drugs preferred but not required.
Experience interacting with Health Authorities including meeting preparation.
Experience managing a team.
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.