Executive Director, Regulatory Affairs CMC in San Mateo, CA

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Industry:

Pharmaceuticals & Biotech   •  

15+ years

Posted 8 weeks ago

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Job Description



Are you ready to be a strategic leader helping Gilead develop and deliver life-saving therapies? Are you prepared to use your scientific knowledge to play a critical role in leading teams and partnering with internal groups and external agencies as we strive to cure unmet medical needs around the world?

We are looking for an Executive Director of Regulatory Affairs CMC who is ready to dive in and lead teams that make a difference while developing your career. In this high visibility role, you will provide strategic and operational leadership in all CMC regulatory activities related to Gilead's business and therapies. You will work cross-functionally as well as globally.


Gilead is focused on developing life-saving therapies for unmet needs. As as Executive Director, you will be a key leader working with the business and external agencies to help get our therapies approved. You will be a part of an expert and supportive team that fosters constructive collaboration and gives each person a voice.


Responsibilities

  • Manage the tactical operations of US-based Regulatory Affairs CMC teams with responsibility for performance management and staff development.
  • Responsible for ensuring the development, and execution of strategy to support global development programs, new drug applications and key post-approval change control implementation plans for small molecules, biologics, and drug-device combination products in the US and Japan.
  • Work across all levels of business within Gilead to communicate complex CMC issues and deliver updates on major CMC regulatory guidance.
  • Form ad-hoc teams to address critical CMC issues on behalf of project and departmental teams.
  • Build partnerships, and maintain positive image of Gilead with external health authorities, trade groups, and associations.
  • Ensure CMC dossiers meet ICH format and content requirements, as well as specific local requirements of individual countries.
  • Lead the preparation of risk assessments on major global CMC regulatory issues.
  • Maintain current working knowledge of regional and global regulatory requirements, analyze current trends and anticipate changes in the regulatory requirements to adjust strategic plans as appropriate .
  • Initiate and contribute to local and/or global process improvements, which have a significant impact for the CMC Regulatory Affairs Department, and the Pharmaceutical Development and Manufacturing organization.
  • Use your industry network to maintain an awareness of CMC methodologies and disseminate this information to the business.


Knowledge, Experience and Skills

  • Minimum 15 years of relevant experience in Regulatory Affairs CMC, specifically extensive experience with small molecule programs is required .
  • Experience leading large cross functional multi-layer teams
  • Additional experience in Biologics programs and drug-device combination products is desirable. Technical experience within the (Bio-) Pharmaceutical Industry can be partially substituted for Regulatory experience.
  • Requires a Bachelor's degree in a relevant scientific discipline. An advanced degree is preferred .
  • Must have in-depth knowledge of US regulatory requirements, including ICH. Previous experience of RA-CMC requirements for Japan, and other ex-US countries is desirable.
  • Demonstrated success as a people manager and leader, with strong staff development skills.
  • A proven track record of developing global CMC strategies.
  • Excellent verbal and written communication and interpersonal skills.
  • Demonstrated ability to influence across broader functional disciplines.


About Gilead Regulatory Affairs

Gilead Regulatory Affairs CMC is a phenomenal place to develop as a leader. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while also supported and developed by our diverse team.

We are a committed team of highly skilled CMC Regulatory Affairs Professionals dedicated to helping deliver lifesaving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do.

We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career.

Are you ready to explore how you can play a vital role on the team and help deliver life-saving therapies to patients around the world?


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