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 : ~~~ or call Rose Chu at ~~~ for discussion. Video interview to HIRE. Starting ASAP.

The Regulatory Affairs Senior Specialist is responsible for preparing, reviewing, and submitting regulatory agency submissions

TASKS

• 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 : ~~~ or call Rose Chu at ~~~ 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 ~~~ / ~~~ (~~~) for questions. Our technical recruiter/manager will contact the qualified candidates IMMEDIATELY to set up interviews.

Rose Chu

Pharma, CRO and Medical Device Service

Experis

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