Syngene Released Job Openings On 17/09/2022.Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife.
Vacancy Details:
Syngene Recruiting B.Pharm / M. Pharm / Life science Graduates with 5-10 years of research experience for Quality Assurance – Regulatory Affairs Position.Complete Details for the Quality Assurance – Regulatory Affairs as follows.
Important Details :
- Location :Bangalore
- No of Vacancies:01
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 17/09/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Job Description/Skills Required
- Products will typically involve novel molecules in various stage of development and marketing. He/she will be involved throughout the development cycle. His/her contribution will help bring the much needed therapeutics to the unmet need of the patients, thereby positively impacting the mankind.
- He/She will predominantly cater to Developed countries and to certain Emerging countries, based on the market requirement. Responsible for planning, consulting and compiling the CMC portion of the company’s product / clients’ filing into specific international markets.
- Actively participate from initiation of the projects and provide Regulatory strategy inputs to the team and the clients. Will review dossiers, regulatory documents, response to deficiencies, on timely basis as per the business needs and regulatory norms. He/she will support to ensure timely submission and registration as per launch schedule.
- He/she will have a critical role in assessing and providing consulting for the regulatory requirements for various business aspects, especially for USFDA, EU countries, and in support of the Pre-Approval Inspections as required.
- He/she will provide consulting in regulatory compliance throughout the product development cycle as required, for both Indian and international regulations.
- Engaging with the clients on periodical basis to provide the project update, and will be responsible for Regulatory project management for the products assigned.
- He/she will require to travel to other sites within Karnataka. May travel about 30% of the time.
- Identify the regulatory requirements for International Regulatory Dossiers, Prepare checklists, author sections of dossiers and device master files, follow up with stakeholders
- Actively participate in CMC IND, NDA, MAA, ANDA content development as per project schedule. Ensure appropriate standards and content requirements are met for regulatory submissions. Compile, author and Publish eCTD Dossiers.
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