Director, CMC Regulatory Affairs

Location
South San Francisco, CA, United States
Posted
Jul 26, 2021
Ref
1328718516
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Graphite Bio is a clinical-stage biotechnology company focused on harnessing the power of targeted DNA integration. Graphite Bio uses next-generation CRISPR based technology platforms for developing curative gene correction-based stem cell therapies for serious and life-threatening genetic diseases with inadequate existing treatment options

The Role:

Graphite Bio is seeking an outstanding candidate to manage and direct the company's CMC regulatory affairs, including formulation of all strategies and tactics to accelerate the clinical development and commercialization of pharmaceutical products.

What You Will Bring:
    • Develop short and long range CMC regulatory plans and strategies for the Company
    • Oversee and assist in drafting CMC sections of regulatory filings
    • Manage CMC aspects of preparing compliant electronic submissions (and as appropriate, paper submissions) to Regulatory Agencies.
    • Serve as primary interface with FDA and other regulatory agencies for CMC topics
    • Work with development teams to assure high quality CMC submissions and robust clinical development plans.
    • Architect CMC strategies to enable manufacturing process improvements while assuring compliance with regulatory submissions and licenses.
    • Manage CMC regulatory submission timelines in accordance with project plans. Maintains submission tracking information and informs project teams and management on real time status of business critical submissions.
    • Oversee the evaluation and analysis of the impact of trends emerging from relevant regulatory agencies on our CMC development and manufacturing procedures and processes.
    • Review product development and in/out licensing and partnership opportunities for relevant CMC regulatory implications.
    • Serve as a resourceful and informative team member within the company on using templates and other authoring tools to support regulatory submission activities.


What You Will Bring:
    • 7+ years experience in pharmaceutical regulatory activities
    • BS or BA in science/technology or an equivalent combination of education and experience.
    • Current and strong working knowledge of electronic document and submission standards and requirements applicable to the US regulatory environment
    • Advanced skills in the use of MS Word, Adobe Professional and other document publishing tools.
    • Experienced in eCTD publishing.
    • Experienced in managing web-based content and document management environments (eg SharePoint, EDMS solutions).
    • Proven project management skills to support planning and coordination of large regulatory submissions.
    • Ability to work independently and to be innovative in tackling operational challenges.
    • Demonstrated success leading and scaling teams and proven ability to positively impact company culture and demonstrate flexibility in fast-paced environment
    • Excellent team-building, project management, and communication skills


Fit with Graphite Bio's culture:

Ability to build strong relationships with co-workers of various backgrounds and expertise

Ability to function at a high level in a team setting whether leading the group or acting as an individual

contributor

Values-based leadership consistent with Graphite Bios' Core Values

Excitement about the vision and mission of Graphite Bio

Flexibility

Integrity

Compensation/ Benefits:

Competitive salary with equity

Health benefits

Graphite Bio is an equal opportunity employer, and all qualified applicants will receive consideration for

employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national

origin, protected veteran status, or disability status, or any other characteristic protected by law.