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: ...@experis.com or call Rose Chu at 215-###-#### 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: ...@experis.com or call Rose Chu at 215-###-#### 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-###-#### / ...@experis.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-###-####...@experis.comwww.experis.com