Executive
2 weeks ago
Key Responsibilities: 1. Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW). 2. Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, emerging markets). 3. Prepare, review, and manage high-quality regulatory submissions including INDs/IMPDs, BLA/MAA, CTA, DSUR, Annual Reports, as applicable. 4. Post-approval changes (variations, amendments). 5. Liaise with global regulatory agencies to facilitate product approvals and resolve queries. 6. Collaborate with R&D, Quality, Clinical, and national regulatory teams to ensure regulatory compliance across product lifecycle. 7. Provide regulatory guidance during product development, tech transfer, and clinical trial execution, as appropriate. 8. Monitor and interpret evolving global regulations, guidelines, and industry trends related to product category. 9. Provide interpretive analyses of regulatory guidance, regulations, or directives that impact product(s) or CMC operations. Qualifications: 1. Master’s degree (M.Sc./M.Pharm/M.Tech) in Life Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline. 2. Minimum 5-7 years of regulatory affairs experience, with a strong focus on biologics (including mAbs, biosimilars, vaccines, or novel biologics) in the emerging markets. 3. Solid understanding of ICH guidelines, FDA, EMA, and other emerging market regulatory frameworks. 4. Experience in IND / BLA submissions, and lifecycle management of biological products. Note: • Assistant Manager - 7 Years - 1 Position • Senior Executive - 5 Years - 2 Positions
-
Packing Store Executive
4 days ago
Vapi, India The Executive Full time**Job Description for Packing Store Executive (Plastic Industry)** **Position**: Packing Store Executive **Location**: Dungra, Vapi **CANDIDATE SHOULD BE FROM PLASTIC INDUSTRY ONLY** **Key Responsibilities** - **Packing Management**: - Supervise and coordinate the packing of plastic products as per company standards and customer requirements. - Ensure...
-
R&d Executive
2 days ago
Vapi, India The Executive Full time**R&D person Job Responsibility: - ** 1) To conduct experiments in R&D for development of process technology for new product 2) To conduct experiments in R&D for improvement, trouble shooting in existing and new product 3) Literature review and design of experiment for development of product. 4) Follow departmental & other concern department SOP to ensure...
-
IT Executive
2 days ago
Vapi, India The Executive Full time**IT person Job Responsibility: - ** - Install and configure appropriate software and hardware according to user/system requirements related to computer, printers, scanners, networking etc. - To diagnose hardware/software faults and solving technical problems in a timely manner related to service issues or requested by employees. - Identify & place order...
-
Marketing Executive
1 week ago
Vapi, India The Executive Full timeCreate, maintain, and repair electrical manufacturing and test systems - Providing technical electrical engineering operational support - Provide manufacturability feedback to engineering for potential design improvements - Produce engineering drawings with use of AutoCad **Salary**: ₹10,000.00 - ₹16,000.00 per month **Benefits**: - Cell phone...
-
Purchase Executive
10 hours ago
Vapi, India The Executive Full timeConduct product research and sourcing new suppliers and vendors - Source material, goods, and services and negotiate the most cost-effective contract and deals - Performing inventory inspection and reordering supplies and stock - Conduct market research to remain updated about emerging trends and business opportunities - Inspect stock and report any faulty...
-
Logistics Executive
2 weeks ago
Vapi, India The Executive Full time**Position Title**: Logistics & Supply Chain Assistant Manager **Location**:Pardi & Dungra-Vapi **Job Overview**: **Key Responsibilities**: - **Logistics Management**: - Oversee the day-to-day logistics operations, ensuring timely and accurate delivery of products and materials. - Coordinate transportation logistics, including selecting carriers, route...
-
Sr. Accountant
2 weeks ago
Vapi, Gujarat, India THE EXECUTIVE Full time ₹ 4,80,000 per yearWE'RE HIRINGSenior Accountant (2 Positions)Location: Vapi, GujaratAbout Us:A reputed CA firm offering accounting, taxation, and consultancy services seeks experienced professionals to join our team.Requirements:3–5 years of experience as a Senior AccountantStrong knowledge of accounting principlesProficiency in Tally Prime & MS ExcelAbility to finalise...
-
Lab Technician
2 weeks ago
Vapi, Gujarat, India THE EXECUTIVE Full time ₹ 4,00,000 - ₹ 8,00,000 per year**Job Title:** Lab Technician – Non-Ferrous Metallurgy**Location:** Near Vapi, Gujarat**Industry:** Non-Ferrous Metal (Greenfield Project)**Start Date:** 01 November 2025**Qualification:*** B.Sc. in Chemistry / Diploma in Industrial Chemistry* 3–4 years of experience in non-ferrous metallurgical testing**Key Responsibilities:*** Conduct quality and...
-
Administration Officer
2 weeks ago
Vapi, Gujarat, India THE EXECUTIVE Full time ₹ 3,50,00,000 - ₹ 4,80,00,000 per yearJob Title: Admin & Warehouse Park ManagerLocation: Zaroli Road, Near BhiladEducation: Any GraduateExperience: Minimum 5+ years in administration, facility, or warehousing management (preferred)Package: Best as per experienceJob DescriptionWe are seeking an Admin & Warehouse Park Manager to oversee the daily operations of our warehousing park. The ideal...
-
Injection Moulding
2 weeks ago
Vapi, India The Executive Full timeSet up, heat up, start up, operate, troubleshoot, and adjust process settings on the injection molding and coating equipment per standard - Operate hoists and PIV’s that are required used in the area - Adhere to waste stream profiles - Assist department technical personnel with problem solving and experimental activities - Assist maintenance with...