Colgate Hiring – B Pharmacy Candidates With 1 Year Experience Apply
Colgate hiring Regulatory Affairs Associate. Pharmacy job opening 2022. Pharmacy Regulatory Affairs Associate job opening 2022. B Pharmacy job opening 2022. Pharmacy Regulatory Affairs Associate vacancy. Candidates with bachelor’s degree in pharmacy may apply for the job vacancy at Colgate. Check out all the details on the same below:
Job Title: Associate – Regulatory Affairs
Job Location: # 139208 – Mumbai, Maharashtra, India
Eligbility Criteria & Experience:
What you’ll need…
- BS degree in Pharmacy or relevant education. Advanced degree preferred.
- Minimum 1 year of relevant experience in regulatory affairs, quality or product development in the pharmaceutical, medical devices or similar FMCG industries.
- Understanding of registration and regulatory requirements in Africa Eurasian countries.
Knowledge of industry practices, techniques and standards.
- 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 and meet tight deadlines.
- Fluency in spoken and written English. Knowledge of French language is advantageous.
Who are you…
Product Registration and Life cycle management
- Work closely with and support the Regional Regulatory Affairs Department in 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.
- Keep track of outstanding documentation and notify the relevant Regional Regulatory Affairs manager in a timely manner.
- Alert 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 of 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 tools for assigned products.
Artwork Approval and INCI Creation:
- 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
- Assist with the preparation of International Nomenclature of Cosmetic Ingredients (INCI)
Regulatory intelligence and product advocacy activities:
- 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 the competition.
- Assist Regional Regulatory team in delivering and managing RA assessment
- Assist Regional Regulatory team to deliver Regulatory training and contribute to the Regulatory training plan and modules.
- Ensure participation in key meetings for the regulatory function and provide timely feedback.
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