Director / Senior Director, CMC Regulatory at Achaogen
South San Francisco, CA, US
Position Summary:

Achaogen is seeking a motivated, creative and collaborative CMC regulatory professional to join a fast-paced and innovative organization dedicated to the development of new antibiotics to treat patients with serious multidrug resistant infections. This position will play a key role, building and managing the Regulatory CMC team to support the organization’s objectives.

Essential Functions:

Provide strategic regulatory guidance on FDA and ex-US requirements for clinical development, registration and lifecycle management of pharmaceuticals to the organization and to product teams.
May act as the CMC regulatory functional representative for one or more designated programs.
Contribute to the preparation and/or review of INDs, clinical trial applications and IMPDs and marketing applications and manage or oversee responses to Health Authority queries.
Manage contract staff and vendors as needed to support regulatory activities.
Ensure communication and alignment on CMC regulatory strategy through partnership and communication with internal key stakeholders Participates in and conducts due diligence/licensing evaluations.
Prepare teams for health authority interactions and support or lead interactions under the mentorship of the Head of Regulatory Affairs or Senior Director of CMC Regulatory.
Lead or provide oversight for all interactions with Health Authorities, therefore strong negotiation skills and significant experience in interacting with regulatory authorities is required.
Build and lead the CMC regulatory group within regulatory affairs including mentorship and development of junior team members.

Preferred Skills and Experience:

10 + years of pharmaceutical industry experience with a minimum of 5 years of experience in Regulatory Affairs.
Experience leading Health Authority meetings (FDA and EMA) is required with a minimum of 10 years in CMC regulatory required for Sr. Director level.
CMC technical expertise is required; experience with small molecule development is strongly preferred; additional experience with large molecules would be valuable.
Experience with regulatory oversight of commercial manufacturing activities strongly desired.
Direct and significant regulatory experience with CMC documentation preparation for INDs, NDAs, BLAs, IMPDs, MAAs is preferred.
Strong knowledge of EU and FDA regulations.
Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously.
Expert knowledge of quality regulations, current industry practices, and strong experience with interpretation and application.
Prior experience directly or indirectly managing, mentoring and motivating team members is required.

Preferred Education:

Bachelor’s degree in Pharmacy, Chemistry, Biology or a related science/technical field; Advanced degree preferred.

Preferred Additional Skills:

Strong interpersonal, collaboration, teamwork, leadership, conflict management and negotiation skills.
Ability to influence and present to leadership team.
Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
Current US work authorization required.
Ability to travel domestically and internationally.