Colgate-Palmolive Hiring Associate - Regulatory Affairs Bachelor’s degree in Pharmacy or Life Sciences or relevant education Apply now
Key Responsibilities:
Work closely and support Regional Regulatory Affairs programs
and activities for new product registration and life-cycle management of CP
portfolio. Including and not limited to, product renewals, variations,
notifications and/or new license applications.
Support the regulatory strategy defined at Regional and/or
Global level, and report regularly the progress to Regional RA Department with
relevant important metrics. Particularly in terms of timelines, status of
encouraging data required from other functions and dossier preparation.
Compile documents and data required for high quality and
successful submissions, license renewals and annual registrations, and
maintenance of product registration dossiers for authorities.
Work with the Regional Department in preparing submissions to
Proficient Authorities and Notified Bodies, ensuring timely approval of new
products and life-cycle submissions.
Notify Regional Manager of upcoming renewals and commitments
promptly and inform the tracking of outstanding documentation
Upload and publish electronic Common Technical Document
(eCTD) sequences for medicinal products. Work closely with Global and European
functions to acquire the relevant documents and information for product
dossiers.
Assist in the preparation of Regulatory Standard Operation
Procedures, and in keeping track of revision dates. Handle the distribution
lists of SOP and the archiving in the documentation system (DMS).
Ensure accurate electronic archiving of all documents
submitted to and received from Proficient Authorities and Notified Bodies. As
well as accurate and timely data update of regulatory compliance databases and
tool for assigned products.
Assist the Regional RA Managers in the review of list of
ingredients for labeling purposes (eg. INCI and INDI), & also assist them
with artwork review and approval.
Track Proficient Authority websites and databases for news related to new product registrations and parallel imports from competition.
Qualifications and
Experience:
Bachelor’s degree in Pharmacy or Life Sciences or relevant
education. Advanced degree preferred. Minimum 1 yr. of working experience in
regulatory affairs, quality or product development in pharmaceutical, medical
devices or similar FMCG/CPG companies.
Understanding of registration and regulatory requirements in
European countries. Knowledge of industry practices, techniques and standards,
experience with medicinal products and devices is an added advantage.
Excellent digital literacy, working with electronic
databases, eCTD software, MS Office applications. Also, Adobe Acrobat Standard
or Professional, Google Suite, SAP, DMS, and Authority Regulatory databases and
portals for handling changes and submissions.
Excellent interpersonal skills, good planning and organizing skills, ability to work under stress and meet timelines. Proficiency in spoken and written English. Additional language expertise such as French or German is an advantage
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