Regulatory Affairs Specialist II (Regulatory Publishing)

Location
San Francisco, CA, United States
Posted
Oct 06, 2018
Ref
3282-340-R
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Position Overview

Responsible for supporting the Regulatory Affairs Department across a number of company-sponsored projects.

Under supervision, has primary responsibility for assisting in the assembly of regulatory dossiers for review by senior regulatory affairs management. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Works on complex problems in which analysis of data requires and in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. May determine methods and procedures on new assignments. Under the direction of senior regulatory affairs staff, assists in compiling and preparing 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.. Assists in gathering and assembling information necessary for submissions in accordance with regulations and relevant guidelines. Through formal and one-one training, becomes familiar with the laws, regulations and guidelines governing drug development and approval. Reviews Federal Register for relevant information covering new government policies and guidelines for distribution to the Regulatory Department. Under the direction of senior regulatory affairs staff, 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, provides input on timelines for submissions. Follows general instructions to complete projects. Organizes workday to complete mid-term assignments. Supports other projects as needed, which will include but not be limited to, performing research and compiling materials to develop regulatory strategies.

A minimum of a Bachelors degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 5 years related industry experience is required. A minimum of 2 years hands-on Regulatory Affairs experience is required. Must be able to demonstrate excellent organizational, planning and follow-up skills. Excellent word processing, scientific writing, oral presentation and graphic documentation skills are required. Must be able to demonstrate a good attention to details and be goal-oriented, and quality conscientious. Strong computer skills in Word, Excel and Adobe Acrobat, with a working knowledge of electronic publishing/file management systems are an asset. Ability to use the Internet for research applications is required. Expected to demonstrate a basic understanding of current US regulatory requirements, guidelines and regulations. Strong oral and written communication skills are required. Must be able to adapt to changing priorities and manage multiple tasks.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.