Regulatory Affairs/ Product Registrations Manager

16 hours ago

Mississauga, Ontario, Canada Cerapie Pharma Full time

Cerapie Pharma
is a leading pharmaceutical company committed to improving health and well-being through innovative solutions. Our success is driven by our commitment to excellence, compliance, and a team of passionate professionals.

Role Overview:

As a
Regulatory Affairs/Product Registration Manager
, you will be responsible for managing and coordinating the regulatory activities required for the registration and approval of our pharmaceutical products locally with Health Canada and in various global markets.

Principal Duties and Responsibilities
:

  • Prepare and/or review submissions to Health Canada and FDA 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 domestic and international markets.
  • Prepare submissions in
    eCTD format
    , and create bookmarks and links.
  • Prepare written responses to deficiency letters from regulatory agencies in the stated time frame.
  • Prepare and file post-approval submissions for FDA (CBE supplement, PAS) and TPD (Notifiable Change, Supplement).
  • Maintain approved product monographs to comply with CRP-PMs.
  • Maintained approved drug products for the FDA (Annual Report) and the TPD (Annual Drug Notification).
  • Review and approve various product labelling components and marketing materials.
  • Review internal documentation (master batch records, specifications, labelling, product monographs) for adherence to regulatory guidelines.
  • Assist in global drug product registrations.
  • Other duties as required.

Knowledge, Skills and Abilities:

  • Must have strong technical experience with CMC requirements and can critically analyse scientific data.
  • Strong working Experience of the Canadian
    Food and Drugs Act
    and
    Food and Drug Regulations
    , GMPs, ICH Guidelines and Health Canada Policies and Guidelines
  • Must have experience with publishing eCTD submissions.

Qualifications:

  • Experience: Minimum of
    3 years
    of experience in a pharmaceutical company in CANADA at similar position
    is a MUST
    .
  • Must have experience with publishing eCTD submissions.
  • Skills:
    Strong organizational, team management, communication, and problem-solving skills. Attention to detail and ability to work under tight deadlines.
  • Knowledge:
    In-depth and hands on the global regulatory requirements and guidelines.
  • Education: D
    egree in Science, Pharmacy or a related field.
    Is a MUST
  • Proven experience working with regulatory authorities in multiple countries and understanding diverse regulatory environments.

This position is open to applicants legally authorized to work in Canada.

If you are a meticulous professional with a passion for regulatory compliance and product registration, we would love to hear from you. Apply now to join our team and ensure our products make a positive impact worldwide

Send your resume and cover letter to

with the subject line "
Regulatory Affairs/Product Registration Manager Application
".

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