117 Submission Jobs - Page 2

Regulatory Affairs Associate Responsible for preparation, review & submission of regulatory documents (US FDA, EMA, ICH), ensuring compliance with guidelines, supporting product approvals, maintaining records & coordinating with authorities. Required Candidate profile BSC/MSC/B.Pharm or Life Sciences graduate with knowledge of regulatory guidelines, dossier prep, submission processes, documentation, compliance, MS Office, attention to detail & communication skills.

Role & responsibilities Regulatory Submissions Manage all submissions and maintenance activities related to Branded/Specialty and Generic products in APAC region. Ensure full compliance of marketed products according to local regulations by proactively managing and monitoring change control with sites/suppliers and global RA WP. Manage local regulatory planning process for post-approval changes, including variations, site transfers and compliance related activities to support supply continuity. Manage activities within Regulatory Systems and keep up to data as per compliance requirements (GRIDS, GI Insights, Teva Art, Veeva etc) Regulatory Intelligence/Expertise/Guidance/Education Provide re...

Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge o...

Should have exp in Regulated(EU /US) Pre-approval filings New marketing authorizations New dossier submissions to regulatory agency Review technical documents prepare Type IA /IB/II variations prepare submissions license variations & renewals Required Candidate profile Candidates having experience in Regulatory Affairs of Regulated Market should only apply Excellent written and verbal English communication sunil@flamingopharma.com,hr@flamingopharma.com

REQUIRE EXPERIENCE IN MODULE 1 COORDINATION AND SUBMISSIONS. MAIN PURPOSE OF ROLE Experienced professional individual contributor that works under limited supervision. Applies subject matter knowledge in the area of Regulatory Affairs. Requires capacity to apply skills/knowledge within the context of specific needs or requirements. MAIN RESPONSIBILITIES As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. Interacts with regulatory agency to expedite approval of pending registration. Serves as regulatory liai...

Responsibilities: * Lead generation through email campaigns * Collaborate with the sales team on lead nurturing * Meet monthly marketing targets * email marketing * Report results regularly, contact form submissions

Greetings!!!! We are seeking experienced professionals in Regulatory Affairs US Market (CMC, Module 3) with expertise in Formulation, for our Hyderabad-based R&D Centre. Regulatory Affairs US Market (CMC) with strong exposure to ANDA/NDA submissions and post-approval changes. Key Responsibilities: Hands-on experience in US Regulatory Affairs for ANDA & NDA (Approved and Tentative) submissions. Responsible for filing supplements : CBE, CBE-30, PAS, Controlled Correspondence, Annual Reports/Updates. Planning, reviewing, and timely submission of assigned projects in compliance with FDA guidelines . Strong interpretation of FDA queries and drafting of high-quality responses. Review and preparati...

Key Responsibilities: Pick up parcels / documents from specified client locations Ensure timely and safe delivery of documents to clients / business locations. Submit visa applications to the relevant embassy or visa processing center as per the guidelines of the seniors Ensure timely and proper submission as per standard procedures. Plan the schedules beforehand to avoid last minute hassle Communicate politely and professionally with clients / submission counters Ensure accurate labeling, packaging of the documents for the courier Handling courier documents with care and ensuring safe, undamaged delivery. Submission of the courier documents on a timely basis Support inventory management by ...

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a Trusted Emerging Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top managem...

expertise in government and service-based tenders, GEMS portal, documentation, bid preparation, and filing. Responsibilities include tender identification, submission, Strong analytical, communication, and negotiation skills required.

Carries out tasks requiring physical presence at various locations. Customer service Reporting performance metrics Route Following Deliverable Collection and Submission Perks and benefits ESI

Carries out tasks requiring physical presence at various locations. Customer service Reporting performance metrics Route Following Deliverable Collection and Submission Perks and benefits ESI

Carries out tasks requiring physical presence at various locations. Customer service Reporting performance metrics Route Following Deliverable Collection and Submission Perks and benefits ESI

Carries out tasks requiring physical presence at various locations. Customer service Reporting performance metrics Route Following Deliverable Collection and Submission Perks and benefits ESI

Carries out tasks requiring physical presence at various locations. Customer service Reporting performance metrics Route Following Deliverable Collection and Submission Perks and benefits ESI

Carries out tasks requiring physical presence at various locations. Customer service Reporting performance metrics Route Following Deliverable Collection and Submission Perks and benefits ESI

Carries out tasks requiring physical presence at various locations. Customer service Reporting performance metrics Route Following Deliverable Collection and Submission Perks and benefits ESI

Carries out tasks requiring physical presence at various locations. Customer service Reporting performance metrics Route Following Deliverable Collection and Submission Perks and benefits ESI

Aware about PPAP documentation, Process flow diagram, Process control plan, Fabrication , welding, Fluid transmission part, hydraulic tube and pipe, casting and Required Candidate profile Machining parts process awareness. Metallurgy report understanding. MSA, SPC awareness. Daily , weekly and monthly basis report submissions.

Job Title: Regulatory In-charge (Semi-Regulated Markets) Company: GenAide Pharmaceutical Pvt Ltd Location: 909, Satyamev Eminence, Science City Road, Near Shukan Mall, Sola, Ahmedabad, Gujarat 380060 About GenAide Pharmaceutical Pvt Ltd: GenAide Pharmaceutical Pvt Ltd is a young, energetic, and rapidly growing pharmaceutical company committed to delivering high-quality healthcare products. We foster a dynamic work environment with a strong emphasis on teamwork and innovation. Join our already developed team and contribute to our exciting journey! Experience: 5 - 6 years in Regulatory Affairs, with a strong focus on semi-regulated markets. Job Summary: GenAide Pharmaceutical Pvt Ltd is seekin...

Overview Please refer JD Responsibilities Please refer JD Qualifications Please refer JD

Description1 Training Quality Management & Capturing Market Practices - Ensuring Post training interviews & site visits and based on feedbacks, work on improving training delivery in consultation with BM - Training Content Ensuring CUSP customer usage and practices visit every month along with U&A portal updation and questionnaire filling 2 Training Delivery & Capability Building - Ensuring that the Training Delivery is as per the guidelines shared by CA BM - Training Content, Regularly evaluate the capability of TA/helper painter, and train them 3 Participant Management & Tracking - Participants Profiling to enable training in a structured manner 4 CA Management: Commercial & Infra -1 Im...

Job Role and Responsibilities Assist in implementing SEO strategies to optimize website content and improve search rankings. Conduct keyword research and analysis to identify opportunities for content optimization. Collaborate with the marketing team to develop and execute digital marketing campaigns. Help in tracking and analysing key performance indicators (KPIs) for online campaigns. Stay up to date with the latest trends, best practices, and updates in the digital marketing landscape. Support content creation by ensuring it follows SEO guidelines and drives engagement. Assist in the management and optimization of social media platforms and online presence. Skills Requirement Bachelor's d...

In this role, you will be responsible for preparing, reviewing, and finalizing detailed cost estimates for prefab construction projects and tenders. You will need to conduct comprehensive pre- and post-tender document checks to ensure accuracy and compliance. Additionally, you will be required to perform detailed rate analysis for all project components and maintain an up-to-date rate library. Your responsibilities will also include compiling and submitting final costing sets for tenders and projects within stipulated deadlines. It will be crucial for you to ensure that all estimation documents are complete, accurate, and aligned with project requirements. You will need to communicate costin...

Role & Responsibilities: Ensure compliance with applicable laws, regulations, and guidelines related to the company's products or services. Regulatory Submissions: Prepare, review, and submit regulatory documents to relevant authorities, such as product registrations, notifications. Documentation Management: Maintain accurate and up-to-date regulatory documentation, including product technical files, labeling, and manufacturing records. Collaborate with cross-functional teams to provide regulatory guidance and support during product development stages. Review product specifications and documentation to ensure compliance. Regulatory Liaison: Communicate and interact with regulatory authoriti...