Tata Consultancy Services(TCS) Released Job Openings On 22/12/2022.Tata Consultancy Services is an Indian multinational information technology services and consulting company headquartered in Mumbai. It is a part of the Tata Group and operates in 149 locations across 46 countries.Eligibility Criteria / Educational Qualification, Official Notification, Apply Online Form Link & Other Relevant Details for Tata Consultancy Services(TCS) Recruitment 2022 are provided below. Interested and eligible can submit application along with resume.
Vacancy Details:
Tata Consultancy Services Recruiting graduates with 05 to 08 years experience for Regulatory Affairs Specialist Position.
Important Details :
- No of Vacancies:Not Disclosed By Recruiter
- Details of Salary: NA
- Opening date for online Application:22/12/2022
- 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
Related Job: Cognizant Hiring B.Pharm,B.Sc FRESHERS
Job Description/Skills Required
Technical/Functional Skills:
The Regulatory Affairs Specialist should provide direct Worldwide Regulatory support to various projects and products. Candidate should support for strategic planning and product development efforts, provide Regulatory support for existing products with respect to product changes/modifications, labeling and promotional material review and approval.
- Knowledge of FDA regulations and CE, China registration
- Excellent communication skills, both verbal and written.
- Good organizational skills.
- Good analytical thinking, problem solving and investigative skills
Roles & Responsibilities:
- Writes, coordinates and completes the submission of Regulatory documents to FDA and other Regulatory agencies (e.g. EPA). Includes international documents (e.g. tech files, etc.)
- Prepares responses to FDA questions and other Regulatory correspondence
- Provides direct Regulatory support to project teams including the creation of detailed Regulatory Plans
- Includes in-depth team involvement including Core Team membership
- Conducts product labeling and advertising review and approvals
- Evaluates proposed product modifications for Regulatory impact. Completes Regulatory Assessments as needed
- Other activities as assigned including special projects, as needed
- Perform other work-related duties as assigned by the manager of the role
- 510(k)s and determinations as to whether a device modification may trigger the need for a new 510(k)
- European Technical Files, including maintenance and change assessments.
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