Colgate-Palmolive Associate
- Regulatory Affairs, Bachelor’s degree in Pharmacy or Life Sciences or
relevant education
This position is responsible for assisting with the
regulatory operational activities of global development programs, providing
regulatory support for worldwide registrations and maintenance of products
throughout the whole life-cycle primarily for medicinal products and medical
devices, and also for any other category of products, for the European
Division. This position will report to
the Team Lead – North America/Global.
Work closely with and support Regional 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 Regional and/or
Global level, and report regularly the progress to Regional Regulatory Affairs
Department with relevant KPIs, particularly in terms of timelines, status of
supportive data required from other functions and dossier preparation.
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 Regional Regulatory Affairs Department 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
Regional Regulatory Affairs Manager in a timely manner.
Inform Regional 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
medical devices and biocides.
Upload and maintain as required by the Regional RA team any
documentation supporting the placing on the market of other categories of
products eg cosmetics, home care, consumer goods
Work closely with Global and European functions to obtain the
relevant documents and information for product dossiers.
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 tool for
assigned products.
Assist the Regional Regulatory 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 to the applicable regulatory and corporate
standards/requirements (medicinal products, medical devices, cosmetic products,
biocides, detergents, consumer goods).
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 new product registrations and parallel imports from competition (UK
and Germany).
Qualifications and Experience
Bachelor’s degree in Pharmacy or Life Sciences or relevant
education. Advanced degree preferred.
Minimum 2 years of relevant 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.
Knowledge and experience with medicinal products and medical
devices is an advantage.
Excellent computer skills, which includes working with
electronic databases, eCTD software, MS Office applications (working with
templates, and editing and formatting complex documents), Adobe Acrobat
Standard or Professional, Internet and Intranet, Google Suite, SAP, DMS, and
Authority Regulatory databases and portals for managing changes and
submissions.
Good written and verbal communicator with excellent
interpersonal skills.
Good planning and organizing skills.
Ability to work under stress and meet deadlines.
Fluency in spoken and written English. Knowledge of any
additional language such as French or German is an advantage.
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