Evertogen Life Sciences Limited Walk In Interview 2023. Evertogen Life Sciences Limited Notification full details below.Interested and eligible candidates can attend interview on scheduled time and venue.Evertogen develop, manufacture and market finished dosages for companies around the world. With well-planned and equipped processes & systems in place, we cater to the requirements of our clients in a timely and cost-effective manner, bringing greater predictability to their business.
Vacancy details:
- Post Name: Assistant Team Leader/ Team Leader- Regulatory Affairs-OSD Formulation
- Qualification: B. Pharmacy/ M. Pharmacy
- Experienced:5 to 8 years of relevant experience in formulations.
Job Description: Greeting from Evertogen Life Sciences Limited !!!!
Important Details :
- Location: Hyderabad/Secunderabad
- Post of date:03/03/2023
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to Face interview
- Interview Rounds of Interview: HR
Roles and Responsibilities
- Preparation and review of MA dossiers of formulations for submission to EU/ROW markets in CTD and eCTD formats.
- Responsible for completing and submitting ANDAs in eCTD and CTD formats to the US FDA.
- Expertise in EU post-approval variation package requirements (Type I and Type II).
- Handling of queries received from regulatory authorities and customers.
- Responsible for Indian Regulatory
- Ability to understand and apply regulatory guidelines (EUROPE, USFDA, CANADA, TGA, ROW)
- Organizing and coordinating regulatory inspections such as those performed by the USFDA, Europe, the TGA, Canada, and Indian regulators (CDSCO, DCGI & DCA).
- Assigned dossier projects on time delivery for different regulated markets.
- Provide expert regulatory input and due diligence activities.
- Ensure that artwork is coordinated with various business functional areas, such as Quality Assurance, Packaging, Procurement, Markets, and Sites.
- Managing the artwork lifecycle in the PLM (Product Lifecycle Management) tool from the initiation of the project to its approval.
- Sharing of product registration transfer details with the plant after approval/closure of the procedure.
- To coordinate with different departments/QA to obtain the technical documents needed for filing.
- Review of PDRs, BMRs, BPRs, raw material/finished product specifications, STPs, CoAs, annual product reviews, stability specifications, protocols, stability data, packaging materials and all regulatory documents.
- Have adequate knowledge of National Regulatory body requirements regarding to WHO-GMP, GMP, Written Conformation, COPP, Manufacturing licenses, Additional Product Manufacturing License, Free Sale, Test License, RLD Import License, Manufacturing and Test NOC, Special Code NOC, Technical Staff, Loan License, Trade License, Neutral code Certificate.
- Maintaining an up-to-date understanding of regulatory legislation and guidelines
Qualifications and Experience:
- B. Pharmacy/ M. Pharmacy and a minimum of 5 to 8 years of relevant experience in formulations.
- A CTC of 5 to 10 lakhs will be offered per annum for this position depending on Qualification and Experience.
- Good Negotiation and Communication skills required.
Candidate suiting above criteria can forward their CV to rohini.barla@evertogen.com
