Colgate-Palmolive Hiring Associate - Regulatory Affairs Bachelor’s degree in Pharmacy or Life Sciences Apply Now
Key Responsibilities and
accountabilities:
Responsibilities may vary from
time to time depending on the need. The
range of responsibilities and accountabilities may include, but not limited to
the following:
Responsible, in alignment with
the internal client, for mapping each of the processes that are transitioned to
the Operations team with clear roles & responsibilities between the
Operations team and the internal Global Regulatory client.
Responsible for delivering
meaningful KPIs in alignment with the entire Operations team
Work closely with and support
South Pacific & India Hub Regulatory Affairs programs and activities for
new product registration and life-cycle management of CP portfolio, including
but not limited to, product renewals, variations, notifications and/or new
license applications.
Support the regulatory strategy
defined at South Pacific & India Hub Regulatory Affairs level, and report
regularly the progress with relevant KPIs, particularly in terms of timelines,
status of supportive data required from other functions and dossier
preparation.
Work closely with global and
regional cross functional teams and South Pacific/Indian-hub Regulatory to
obtain the relevant documents and information for product dossiers.
Compile documents and
information required for high quality and successful submissions, license
renewals and annual registrations, and maintenance of product registration
dossiers for authorities.
Assist the South Pacific &
India Hub Regulatory Affairs in preparing submissions to Competent Authorities
and Notified Bodies, ensuring timely approval of new products and life-cycle
submissions.
Track outstanding documentation
and notify the relevant Hub Regulatory Affairs Manager in a timely manner.
Inform Hub Regulatory Affairs
Manager of upcoming renewals and commitments in a timely manner.
Assist in the electronic
submission of product dossiers, variations and responses to Competent
Authorities.
Update and maintain product
registration and ingredients archives, databases and tracking tools.
Upload and publish electronic
Common Technical Document (eCTD) sequences for medicinal products.
Upload and maintain technical
files/dossier databases for the products.
Upload and maintain as required
by the relevant Hub RA team any documentation supporting the placing on the
market of other categories of products eg cosmetics, home care, consumer goods
Assist in the preparation of
Regulatory Standard Operation Procedures, and in keeping track of revision
dates.
Manage the distribution lists
of SOP and the archiving in the documentation system (DMS).
Ensure proper electronic
archiving of all documents submitted to and received from Competent Authorities
and Notified Bodies, as well as accurate and timely data update of regulatory
compliance databases and tools for assigned products.
Assist the South Pacific/India
Affairs Managers in the review of list of ingredients for labeling purposes
(eg. INCI and INDI).
Assist the RA Managers with
artwork review and approval
Understand current regulations,
guidelines and standards relevant to ensure compliance of dossiers/submissions
to the applicable regulatory and corporate standards/requirements (medicinal
products, medical devices, cosmetic products, home care products, etc.)
Ensure that the content,
organization and overall quality of all regulatory documents are adequate and
compliant with local/regional regulatory requirements, commitments and
agreements.
Track Competent Authority
websites and databases for news related to regulatory developments.
Other Responsibilities:
Assist regional regulatory team
to coordinate, manage and deliver completed RA assessments and routine regional
regulatory project reports.
Assist the South Pacific/India
Hub regulatory teams in regional or global projects as required.
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