Max Neeman Medical InternationalMax Neeman International is India"s leading contract research organization providing full range of clinical development services to small, mid-size and global pharmaceutical, biotech and medical device companies. The portfolio of the services include comprehensive Phase I-III clinical trials, regulatory submissions, phase IV post approval programs & commercialization services.
Assistant Manager - Regulatory Affairs (clinical Trials)
by Max Neeman Medical International in Delhi
Job Description
POSITION RESPONSIBILITIES
The Assistant Manager - Regulatory Affairs will perform the following activities:
*Review the protocol/study outline thoroughly
*Review the clinical data available from the previous studies from the Investigators Brochure (IB)
*Review the stability and manufacturing data available in the Investigational Medicinal Product Dossier
*Review the checklist of the documents required for the submission.
*Review all the documents sent by the client as per the checklist sent to the sponsor.
*Prepare and Review of the complete regulatory dossier for submission.
*Make Regular visits to the regulatory offices to get an update of the approval status and follow-up of the application.
*Escalate any query generated by the regulatory office to the In charge (Regulatory)
*Receive the query generated by the regulatory office and send the scanned copy to the Incharge.
*Review the reply sent by the sponsor in the regulatory office.
*Review the Approval letter for correctness
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Drug Regulatory Affairs/Documentation
Role: Regulatory Affairs Manager
Keyskills: Excellent Communication SkillsExperince in Regulatory Affairs - Clinical Trials
Desired Candidate Profile
Education: UG - B.Pharma - Pharmacy, B.Sc - Any Specialization, Biology
PG - M.Pharma - Pharmacy
Doctorate - Doctorate Not Required
Please refer to the Job description above
Company Profile
Max Neeman Medical International
http://www.neeman-medical.com/
Max Neeman International is India"s leading contract research organization providing full range of clinical development services to small, mid-size and global pharmaceutical, biotech and medical device companies. The portfolio of the services include comprehensive Phase I-III clinical trials,
regulatory submissions, phase IV post approval programs & commercialization services.
Contact Details
Recruiter Name:Neha Sameen
Address: Max House 01, Dr. Jha Marg, Okhla-III NEW DELHI,Delhi,India
Email Address: