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Regulatory Affairs Manager Product Development Small Molecule

Kelly Services

Palo Alto, CA 94301
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Job Details

Regulatory Affairs Manager (Product Development Small Molecule)

Palo Alto, CA

Direct Hire

Salary DOE

Department: Laboratory for Cell and Gene Medicine


+ Collaborate with investigator project teams to manage and coordinate the authoring, review, and finalization of regulatory documents in accordance with submission timelines, keeping all stakeholders, including external partners, informed of progress

+ Support preparation, assembly of clinical, pre-clinical, and CMC information for submissions of Investigational New Drugs (INDs) including amendments, supplements and annual reports for multiple simultaneous submissions for manufactured products across a broad spectrum of biological systems

+ Includes project/submission management; templates; word processing and formatting; proof-reading; bookmarks and hyperlink publishing; and archiving for R&D regulatory documents. This position also executes and maintains processes for managing regulatory submissions, correspondences, and commitments in accordance with Good Documentation Practices. Contribute to installation and maintenance of software for regulatory submissions and documentation

+ Liaise with internal teams such as process development scientists, manufacturing scientists, quality control, quality assurance and clinical research staff and operations

+ Support the development of responses to Health Authority requests and ensure alignment with regulatory CMC strategy. Assist in drafting background packages for meetings with Health Authorities.

+ Support facility licensing and registration, GMP validation activities of cell processing facility and other cGMP/GLP activities (change controls, QSR implementation, SOP and RMS reviews) via direct interactions with QA

+ Inform training required for Regulatory Affairs staff at LCGM

+ Hire and supervise junior RA staff, including: training, coaching, disciplining and termination.


+ Working knowledge of US CMC regulations as well as ICH and US guidance documents required.

+ Bachelor's degree in Life Sciences, advanced degree preferred.

+ Experience in regulatory affairs or other relevant experience in investigational stage biologics.

+ Ability to manage multiple projects/submissions concurrently.

+ Strong leadership, interpersonal skills and the ability to work in a project team environment.

+ Excellent written and oral communication skills in English.

+ Strong technical writing and editing skills.


+ Bachelor's degree and 5 years of relevant experience, or combination of education and relevant experience.


+ Demonstrated ability to establish priorities, manage shifting priorities, and handle numerous time-sensitive projects with multiple deadlines.

+ Ability to accomplish goals working through formal and informal channels, with diplomacy and tactfulness.

+ Demonstrated creativity, problem solving, critical analysis, initiative, judgment and, decision-making skills.

+ Demonstrated ability to develop and meet budget goals.

+ Demonstrated solid planning and organizational skills.

+ Demonstrated experience working independently and as part of a team.

+ Excellent interpersonal, written and oral communication skills.

+ Strong relevant subject matter knowledge.

+ Ability to direct the work of others, for jobs requiring supervision.




+ Constantly perform desk-based computer tasks.

+ Frequently stand/walk, sitting, grasp lightly/fine manipulation.

+ Occasionally use a telephone.

+ Rarely lift/carry/push/pull objects that weigh 11-20 pounds.

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your careerconnect with us today.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect
with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
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