IFF Pharma Jobs – Apply For Regulatory Specialist Post
Job Posting: Senior Regulatory Specialist, Pharma Solutions
Date: Dec 18, 2023
Location: Mumbai, IN, 400051
Company: IFF Family of Companies
Req ID: 493679
Are you inspired to contribute your expertise to a global leading Ingredients organization? We are a global leader in taste, scent and nutrition, offering our customers a broader range of solutions for the food & beverage industry.
We are looking for a dedicated and passionate individual to join our Global Regulatory Affairs (GRA) team as Senior Regulatory Specialist, Pharma Solutions. Come join the global Ingredients leader where science and creativity meet to create essential solutions for a better world!
As Senior Regulatory Specialist, you will be responsible for providing hands-on regulatory support for the development and maintenance of our Pharmaceutical Solutions business within the region. You will be involved in Pharmaceutical Solutions product registrations and direct agency interaction within the region, and as applicable, with other agencies.
The role is Mumbai based and will report to Global Pharmaceutical Solutions Regulatory Affairs Leader.
How You Will Contribute:
- Support to existing product portfolio in their pharmaceutical applications for new market/applications and introduction of existing products into additional countries/jurisdictions within the region.
- Active involvement with new projects and new product developments and supporting dossier work on an as needed basis.
- Provide regulatory support to regional customers directly and can be engaged in regional industry associations (e.g., IPEC) as appropriate.
- Proper involvement in relevant risk evaluation and management processes.
- Involvement with local competent authorities and trade associations (e.g., IPEC), on an as needed basis.
- Support of regional, and as needed global, regulatory issues to the different internal stakeholders (e.g., commercial teams, quality, operations) as well as external stakeholders (e.g., customers).
- Interface with internal business functions to support business plans, development opportunities and R&D objectives.
- Involvement with customer regulatory filings as needed in alignment with IFF policies.
- Develop, submit and support regional dossiers for approval of excipients.
- Provide regional regulatory input during cross functional business projects.
- Master’s or Bachelor’s degree in Pharmaceutical Science, Regulatory Science, Biology, Toxicology, or Chemistry or any other relevant discipline.
- At least 5 years of Regulatory Affairs work experience in the Pharmaceutical Industry with excipients.
- Knowledge on the global and regional regulatory landscape for pharmaceutical excipients and their use in finished drug products.
- Global and/or regional experience in interaction with regulatory agencies and track record in product clearance/registrations and regulatory advocacy.
- Subject matter expertise on EU and US pharmaceutical regulations, excipients.
- Knowledge of FSSAI regulations for Nutraceutical and dietary use will be an added advantage.
- Demonstrate analytical, conceptual and strategic thinking as well as excellent communication skills across a global team.
- Strong interpersonal skills.
- Very good organization, and project management competencies.
- Strong influencer and collaborator with interdisciplinary teams.
- Willing to travel to support Indian business-customer interactions, trade associations or interacting with government officials.
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