Current Open Positions
MedPharm General Trading LLC welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. Our opportunities are available in hybrid settings.
Associate, Regulatory Affairs
April 22, 2022
Location: Remote
Deadline: September 30th, 2022
Duties: Plan, coordinate, compile and file drug product submissions for Canada . for a variety of dosage forms (solid oral, liquids, topical semisolids and injectables) in eCTD format (e.g. DMFs, ANDS, NDS, ANDA, NDAs, S/NDSs, DINs, CTAs, NCs, INDs, provincial. formulary submissions.
etc.) for the successful registration of drug products for regulated international markets.
B. Sc. in a Chemistry, Pharmacy pipeline combined with at least three (3) to five (5) years of hands-on Regulatory Affairs experience in filing and managing USA submissions, including electronic submissions in eCTD formats. Expertise in chemistry and manufacturing, labelling and format requirements for drug product registration for FDA (ANDA, NDA, DMF, IND) and TPD (CTA, ANDS, S/ANDS, NDS, DIN, DMF). Knowledge of the use of eCTD Software for preparing and filing submissions is preferred. Knowledge of GMP requirements and QA/QC procedures. Ability to plan, coordinate and work effectively in a team-oriented environment. Superior computer software skills (Microsoft Word, Excel, Access, PowerPoint, Adobe Acrobat, Document Management Systems). Good problem-solving abilities are required to prepare written responses to deficiency letters from regulatory agencies, as well as obtain approval of changes to approved drug products.