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22 days old

Regulatory Affairs Associate - CMC

Kelly Services
Cherry Hill, NJ 08034
**Regulatory Affairs Associate - CMC**


Cherry Hill, NJ


**Summary:** Responsible for the preparation of ANDAs, amendments, and supplement applications to OGD and FDA for approval, which includes responding to any deficiency letters related to ANDA submissions.


**Duties and Responsibilities:**


+ Reviews labeling for new products and revisions for existing products.

+ Proofreads labeling drafts as requested by labeling.

+ Completes regulatory portion of Annual Product Reviews (APRs).

+ Reviews Change Control Requests (CCRs) and provides regulatory opinion with supervisor concurrence.

+ Participates in multidisciplinary project teams for new products.

+ Provides regulatory advice to teams and gives updates at regulatory staff meetings as needed.

+ Prepares annual reports, annual product reviews and writes periodic bulletins, prepares supplements, amendments, and other correspondences.

+ Participates and becomes involved with various tasks force teams, as designated by the manager and will act as regulatory liaison to specially assigned R & D project teams.


**Qualifications:**


+ Bachelors degree in a scientific discipline with 2-5 years industry experience in pharmaceuticals

+ Two years regulatory experience strongly preferred!

+ Experience in injectable drug product preferred

+ Exercise independent judgment.

+ Scientific knowledge.

+ Written and Verbal communication skills.

+ Strong Negotiation skills.

+ Technical system skills (e.g. word processing, spreadsheets, databases, online research).

+ Manage multiple projects and deadlines.

+ Ability to identify compliance risks and escalate when necessary.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


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


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-11-15 Expires: 2021-12-16

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Regulatory Affairs Associate - CMC

Kelly Services
Cherry Hill, NJ 08034

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