Colgate Regulatory Affairs Pharma Job – Minimum 1 Year Experience
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Job Title: Associate – Regulatory Affairs
Relocation Assistance Offered Within Country
Id: 145192 – Mumbai, Maharashtra, India
- 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 Asia Pacific countries.
- Knowledge of industry practices, techniques and standards.
- Excellent computer skills, which includes working with Google Suite, electronic databases, eCTD software, MS Office applications, Adobe Acrobat Standard or Professional, 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 is mandatory.
- 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 the 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 and Notified Bodies.
- Keep track of outstanding documentation and open queries from Authorities, and notify the relevant Regional Regulatory Affairs manager in a timely manner.
- Update and maintain product registration and ingredients archives, databases and tracking tools.
- Upload and maintain as required by the Regional RA team any documentation supporting the placing of the market of other categories of products e.g. cosmetics, home care, consumer goods.
- Work closely with Asia Pacific and Global business partners to obtain the relevant documents and information for Product Dossiers, Product Information Files, and Special Certifications (i.e. – Halal Certifications)
Assist the Regional Regulatory Affairs managers in creating and reviewing the list of ingredients for labelling purposes (e.g. INCI and INDI).
Assist the Regional Regulatory Affairs managers with artwork review and approval
Regulatory intelligence and product advocacy activities:
- Understand current regulations, guidelines and standards relevant to ensure compliance to the applicable regulatory and corporate standards/requirements (cosmetic products, drug products, medical devices, etc.).
- Track Competent Authority websites and databases for news related to new product registrations and parallel imports from competition.
- Assist Regional Regulatory team to deliver and manage Regulatory Assessment
This position will manage and maintain product compliance during the whole life-cycle, for any category of products, specifically for products marketed in Asia Pacific. This position will report to the Team Lead, Regulatory Operations.
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