Sr. Manager, Regulatory Operations at Achaogen
South San Francisco, CA, US
Position Summary:

In managing the Regulatory Operations functions at Achaogen, this position has oversight of all aspects of regulatory operations, which are integral to the success of timely regulatory submissions to the FDA and ex-US regulatory authorities; seeks to continuously improve processes and systems critical to the regulatory success of program goals (eg, marketing applications); and ensures processes and procedures related to regulatory publishing and submissions are in accordance with applicable regulations and established business standards.

Essential Functions:

Lead the regulatory submissions team in publishing, submitting, and archiving of INDs, CTAs, marketing applications (NDAs, MAAs), annual reports, safety reporting, labeling, and regulatory correspondence.
Ensure submissions are of high quality and meet all relevant standards and technical requirements.
Utilize document management and publishing tools to support efficient and flexible processes for the development of regulatory documents through submission to regulatory authorities and archiving.
Ensure processes employed to develop, package, and submit content for regulatory submissions are defensible under regulatory inspection (eg, pre-approval inspection).
Maintain all regulatory document templates and document development support to all Development functions in partnership with Regulatory Writing.
Manage regulatory submission timelines in accordance with project plans as well as submission tracking information and communications to project teams and senior management on real-time status of business-critical submissions.

Preferred Experience:

A minimum of at least 5 years working in the pharmaceutical or biotech industry and 3 years in a Regulatory Operations management role.
Current and strong working knowledge of electronic document and submission standards and requirements applicable to the US and EU regulatory environments.
Advanced skills in the use of MS Word, Adobe Professional and other document publishing tools.
eCTD publishing and submitting of INDs as well as NDAs/BLAs.
Developing processes for and managing electronic document management systems (eg, SharePoint).
Proven project management skills to support planning and coordination of large regulatory submissions.
Excellent communication skills and effective in a collaborative team environment.
Ability to work independently and to be innovative in tackling operational challenges.

Preferred Education:

Ideally a BS or BA in science/technology or an equivalent combination of education and experience.
Training and advanced knowledge in ICH eCTD and global electronic submissions requirements.

Preferred Additional Skills:

Committed to the values of integrity, accountability, transparency, scientific rigor, and drive.
Current US work authorization required.
Ability to travel domestically and internationally.