Regulatory Affairs Associate

Regulatory Affairs Associate

08 Jan 2025
Kansas, Overlandpark, 66204 Overlandpark USA

Regulatory Affairs Associate

HIRING a Regulatory Affairs Associate for a global leading Clinical Research Organization This is a fully REMOTE (EST/CST only) opportunity based on W2 or C2C . Looking for an experienced associate mostly worked on CTA(clinical trial applications ). The other members of the team are a senior director of regulatory affairs and a CMC Health person. They submit protocol by protocol and there is no module 2 or 3. Need Health Canada Experience for filling CTAs first in-human submissions. Plus: FDA Experience filing INDs or pre-IND meeting requests and performing regulatory gap assessments . Interested individuals are encouraged to contact or submit their CV to the following email address : rose.chu@experis.com or call Rose Chu at 215-317-2999 for discussion. Video interview to HIRE. Starting ASAP.The Regulatory Affairs Senior Specialist is responsible for preparing, reviewing, and submitting regulatory agency submissionsTASKS:

Prepare, review, and submit Clinical Trial Applications (CTAs) for small drug molecules, biologics, natural health products and combo drug-medical devices to regulatory agencies

Prepare and submit Pre-CTA and Pre-IND consultation meeting with Health Authorities

Consult and communicate with Health Canada/FDA to ensure regulatory requirements are met

Lead important regulatory discussions with Sponsors and Health Agencies

Provide review and gap analysis of regulatory documents

Write, prepare, and review the Quality Overall Summary (QOS) or IMPD

Prepare and review responses to Health Canada and FDA information requests

Maintenance of regulatory submissions (Amendments, Notifications, SAE/SUSAR reporting, study closure)

Prepare, review, and submit exemption application for controlled substances to the Office of Controlled Substances (OCS)

Maintain current awareness on regulatory guidelines (such as Health Canada, FDA, and ICH) and ensure processes are adjusted as necessary

Undertake continuous learning and development on regulations through self-training, workshops and conferences

QUALIFICATIONS:

Bachelor's degree in Life Sciences (Master degree, certifications and trainings in regulatory affairs, asset)

5-7 years’ related experience, in the regulatory field within the pharmaceutical industry required

Thorough understanding of clinical research, drug development process and applicable regulatory guidance

Knowledge of CMC, pharmaceutical manufacturing, and analytical chemistry (asset)

Experience of filing and managing regulatory submissions , including electronic submission in eCTD formats (asset)

Strong computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to various information technology (IT) systems

What's in it for me?

Fully remote

Weekly pay (W2) with health benefit and 401K

Long-term opportunity

Interested individuals are encouraged to contact or submit their CV to the following email address : rose.chu@experis.com or call Rose Chu at 215-317-2999 for discussion. Video interview to HIRE. Starting ASAP.Thank you for taking the time to read this email. Thank you in advance for any referral – We offer up to $1,000 as referral bonus Please forward your credentials in Word format through Indeed or call Rose Chu direct at 215-317-2999 / rose.chu@experis.com (rose.chu@ettaingroup.com) for questions. Our technical recruiter/manager will contact the qualified candidates IMMEDIATELY to set up interviews.Rose ChuPharma, CRO and Medical Device ServiceExperisC: 215-317-2999rose.chu@experis.comwww.experis.comManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.

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