Colgate Hiring Pharma Candidates – Regulatory Affairs Associate
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: Regulatory Affairs Associate
Location: 134902 – Mumbai, Maharashtra, India
Eligibility Criteria:
- BS degree in Pharmacy or Life Sciences or relevant education. Advanced degree preferred.
- At least 1-3 years 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 and 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. Fluency in spoken and written
- French and other languages is advantageous.
Job Purpose:
This position will manage and maintain product compliance during the whole life cycle, for any category of products. This position will report to the Team Lead, Regulatory Operations.
Key Responsibilities:
- 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 the Regional and/or Global level, and report regularly the progress to the Regional Regulatory Affairs Department with relevant KPIs, particularly in terms of timelines, the 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 eg cosmetics, home care, and consumer goods.
- Work closely with Global, European, and third-party business partners 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.
Artwork Approval:
Assist the Regional Regulatory Affairs managers in the review of list of ingredients for labeling purposes (eg. 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 (medicinal products, medical devices, cosmetic products, biocides, detergents, and 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 Regulatory Assessment
Apply Online
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