Nektar Therapeutics, San Carlos, CA
If interested, please email your resume as a MS Word document. Thank you.

Position Summary
Responsible for supporting the Regulatory Affairs Department across a number of company-sponsored projects. Under supervision, has primary responsibility for assembling regulatory dossiers for review by senior regulatory affairs management.

Responsibilities
Works on extremely complex problems in which analysis of data require an evaluation of intangible variables.
Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
Acts independently to determine methods and procedures on new assignments.
Under the direction of senior regulatory affairs staff, compiles and prepares regulatory submissions for Company and partner sponsored global regulatory submissions, including 510(K), IDE, IND, NDA, CTD, CTA, IMPD, MAA, Drug/Device Master Files, Technical Files, Annual Reports, Amendments, Supplements, and etc..
Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
Reviews methods, SOPs, protocols, reports for regulatory compliance and report findings to senior regulatory affairs staff.
Maintains formal and one-one training to become familiar with relevant laws, regulations and guidelines governing drug or device development and approval.
Reviews Federal Register for relevant information covering new government policies and guidelines for distribution to the Regulatory Affairs Department.
Under the direction of senior regulatory affairs staff, prepares departmental special reports, white papers, etc..
Maintains regulatory submissions and correspondence for Company sponsored projects, and all company related sections for partner sponsored projects.
Under the direction of senior regulatory affairs staff, maintains state Drug and Device Manufacturing licenses and monitors status of California Board of Pharmacy exempt certificates.
Under the direction of senior regulatory affairs staff, develops timelines for submissions.

Requirements
A minimum of a Bachelors degree in a scientific discipline is required. Equivalent experience may be accepted.
A minimum of 8 years related industry experience is required.
A minimum of 4 years hands-on Regulatory Affairs experience is required.
Must be able to demonstrate excellent organizational, planning and follow-up skills.

Posted at http://sfbay.craigslist.org/pen/sci/764052191.html