117 Actd Jobs - Page 3

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4.0 - 8.0 years

6 - 6 Lacs

ahmedabad

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We are hiring a highly experienced Senior Regulatory Affairs Executive for our pharma company in Ahmedabad. The role involves dossier preparation & submission (CTD/ACTD/eCTD), product registration, regulatory strategy, compliance with WHO-GMP/ICH/global guidelines, and handling ROW, LATAM, SEA, Africa, Pacific market approvals. The candidate will also coordinate BE studies, manage lifecycle activities, review technical files, liaise with authorities, maintain regulatory records, and mentor junior team members.

Posted 2 months ago

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3.0 - 5.0 years

3 - 6 Lacs

chennai

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Job Description: Regulatory Affairs Executive (ROW Markets) Industry: Pharmaceuticals Experience: 3-5 Years Loaction: Chennai Key Responsibilities: Dossier Submissions: Compile & submit ACTD, CTD, and country-specific dossiers for ROW markets. Regulatory Queries: Prepare and respond to health authority queries on submitted dossiers. Document Review: Review BMR, specifications, COA, MOA, and technical documents for compliance. Artwork Coordination: Ensure accuracy in labeling & packaging artwork with regulatory standards. FDA Compliance: Maintain records for FDA licenses (Product Permission, CoPP, FSC) . Legal Documentation: Track notarized & legalized documents for international submissions....

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4.0 - 6.0 years

8 - 10 Lacs

bengaluru

Hybrid

• Develop and review content for various regulatory documents; ensure quality as per setegulatory standards and compliance requirement. • Good understanding of global regulatory dossier formats and ACTD/CTD/NeeS/paper dossier format. • Candidate will need to author and/or review clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD for submission to the Health Authorities in EU and APAC markets, respectively. Key requirement: • Good medical/pharma/scientific knowledge that can be applied in developing content for regulatory documents • Experienced in the development and review of clinical and non-clinical documents under Module 2, 4 and 5 of eC...

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5.0 - 10.0 years

4 - 8 Lacs

ahmedabad

Work from Office

Role & responsibilities Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD/eCTD guidelines. Response preparation as per the query Preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities requirements Coordination with various departments to collect the necessary information required for preparation of the CTD / ACTD / Country specific dossier. Assist in preparation of dossier as per country specific requirement. Any other job assigned by immediate supervisor/HOD Pr...

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5.0 - 6.0 years

3 - 6 Lacs

ahmedabad

Work from Office

Job Responsibilities: Dossier preparation/review as per country specific guideline/CTD guideline Timely query response submission to Distributor/ MOH Review of documents for its correctness and compliance with respective regulatory guidelines (as per country requirement) Preparation, review & release of artworks & sales order as per country approval Variation documents preparation and filing as per country requirements Timely dispatch of tender documents to country/parties as per deadline Candidate profile Should be able to review & interpret the requirement as per country specific/ tender guideline/Query received from MOH Should be able to review various plant documents for dossier preparat...

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3.0 - 7.0 years

8 - 13 Lacs

mumbai, new delhi, pune

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To drive sales and ensure business targets are achieved o Aggressively drive the sales numbers and achieve the business targets for Retail loan products and through cross selling while continuing to enhance and upgrade the client relationships.o Retain and expand the company's base of customers for retail loan product so as to ensure repeat business or referralso Maximize sales through a network and relationships to ensure strong businesso Develop and maintain strong liaisons with the clients for repeat business or referrals.o Ensure the files are processed from login stage to disbursement and liaise with internal departments (Operations and Credit) for completion.o Optimize team productivit...

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3.0 - 8.0 years

0 - 1 Lacs

Bengaluru

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Lead Analyst- Emerging Markets Strategy: Elevate Your Impact Through Innovation and Learning Evalueserve is a global leader in delivering innovative and sustainable solutions to a diverse range of clients, including over 30% of Fortune 500 companies. With a presence in more than 45 countries across five continents, we excel in leveraging state-of-the-art technology, artificial intelligence, and unparalleled subject matter expertise to elevate our clients' business impact and strategic decision-making. Our team of over 4, 500 talented professionals operates in countries such as India, China, Chile, Romania, the US, and Canada. Our global network also extends to emerging markets like Colombia,...

Posted 3 months ago

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5.0 - 8.0 years

12 - 17 Lacs

Thane, Navi Mumbai, Mumbai (All Areas)

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We are looking for Regulatory Affairs - Executive / Sr. Executive handling Africa and Asia and will be based at Juinagar, Navi Mumbai. Minimum 5 Years in RA is must Roles & Responsibilities: 1. Dossier Preparation and Submission: Compile and review regulatory submissions in ACTD, CTD and formats. Ensure all regulatory documents are accurate, complete, and compliant with regulatory requirements. 2. Review of Plant and R&D Data: Review R&D data to confirm compliance with regulatory expectations and assist in developing effective submission strategies. 3. Regulatory Compliance and Updates: Stay informed of changes in Asian and CIS market regulations, ensuring timely implementation of updates to...

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5.0 - 10.0 years

6 - 10 Lacs

Kolkata

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Incoda Media is looking for Assistance Manager / Manager - Media Sales to join our dynamic team and embark on a rewarding career journey Achieve growth and hit sales targets by successfully managing the sales team Design and implement a strategic business plan that expands company€™s customer base and ensure it€™ s strong presence Own recruiting, objectives setting, coaching and performance monitoring of sales representatives Build and promote strong, long-lasting customer relationships by partnering with them and understanding their needs Present sales, revenue and expenses reports and realistic forecasts to the management team Identify emerging markets and market shifts while being fully a...

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1.0 - 3.0 years

3 - 4 Lacs

Bengaluru

Work from Office

Role & responsibilities We are seeking a Regulatory Affairs Executive with 1 to 3 years of experience in the pharmaceutical industry. The ideal candidate should have hands-on experience in compiling and reviewing ACTD and CTD dossiers for various regulatory submissions. Responsibilities include preparing, compiling, and maintaining regulatory documentation in accordance with regional requirements, coordinating with cross-functional teams to gather necessary data, and ensuring timely submission of dossiers. The candidate should be well-versed with regulatory guidelines, and capable of handling multiple projects simultaneously. Preferred candidate profile Regulatory Affairs, ACTD, CTD, Dossier...

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2.0 - 6.0 years

4 - 6 Lacs

Vadodara

Work from Office

Prepare, compile & submit dossiers for product registration, variations & renewals to regulatory authorities.Ensure compliance with current regulations, guidelines & standards for pharmaceutical products.Knowledge of CTD/ACTD format is must.

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6.0 - 11.0 years

7 - 17 Lacs

Mumbai

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We are seeking a highly experienced and detail-oriented Regulatory Affairs Specialist with 5 to 15 years of experience in the pharmaceutical industry, specifically handling regulatory requirements for ROW (Rest of the World) / PICs (Pharmaceutical Inspection Co-operation Scheme) markets. The ideal candidate will have strong expertise in dossier preparation, international registration processes, and a solid understanding of global regulatory frameworks including ICH CTD, ACTD, and EU CTD formats .

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8.0 - 12.0 years

10 - 13 Lacs

Ahmedabad

Work from Office

Role & responsibilities Develop and implement regulatory strategies to support research projects and product development initiatives. Monitor and interpret regulatory requirements and guidelines related to scientific research, including USFDA, Europe (EMA), UKMHRA, Canada (Health Canada), Brazil (ANVISA), China (NMPA), Australia (TGA), New Zealand (MMDSA) Japan (PMDA) and other relevant international standards. Prepare and submit regulatory filing agency queries with gap analysis, including API DMFs, eCTD details, and other relevant documents, ensuring accuracy and compliance with regulatory requirements. Collaborate with cross-functional teams to integrate regulatory considerations into pro...

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5.0 - 8.0 years

4 - 6 Lacs

Ahmedabad

Work from Office

Role & responsibilities Dossier Preparation in CTD/ACTD/Country Specific Formats 2. Re-registration and Renewal Application 3. Variation Application 4. Queries Handling 5. DMF Activity 6. Artwork Review (Carton/Foil/Label/Insert/Shipper) 7. Pack Insert Preparation as per Country Guideline 8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement. 9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Sea...

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4.0 - 7.0 years

6 - 10 Lacs

Aurangabad

Work from Office

Planning, review & submission of CTD/ACTD/eCTD for export market (Markets will work for Europe / US). Registration/Re-registration/post approval changes application for export market. Resolve the technical query related to product registration/Re-registration/post approval changes. Follow-up and coordination with internal stakeholders. Review of technical documents. Review of artwork and pack insert. Preparation and submission of Product safety update report.

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3.0 - 4.0 years

5 - 6 Lacs

Hyderabad

Work from Office

Knowledge of about Preparation of Dossier. Sound knowledge of about semi regulated and regulated markets like USFDA , EU , MHRA , TGA , ANVISA , Canadian market. Knowledge of addressing regulatory deficiencies. Exposure to regulatory audits. Review of DMF. Knowledge of filling the products to semi regulated markets and regulated markets. Location Hyderabad Apply to Job Send your resume to

Posted 4 months ago

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3.0 - 5.0 years

3 - 4 Lacs

Navi Mumbai

Work from Office

Role & responsibilities Contractual Role for 6 Months. Exploration of updated guidelines needed for dossier compilation for ROW market/ Regulated Market. Preparation, compilation, review, and submission of Pharmaceutical Dossiers to emerging market as per International Conference on Harmonization (ICH) and country specific guidelines in Common Technical Document (CTD), Asian Common Technical Document (ACTD) and regional format. Internal communication & follow-ups with various departments for various documents. To arrange and send samples for registration purpose to various countries. Review at all quality data received from various departments before using in dossiers and technical packages....

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2.0 - 5.0 years

8 - 13 Lacs

Mangaluru

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We are looking for a highly skilled and experienced Customer Service Executive to join our team in Mangalore. The ideal candidate will have 2-5 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Supe...

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2.0 - 5.0 years

8 - 13 Lacs

Mumbai

Work from Office

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Bilaspur. The ideal candidate will have 2-5 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform various tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of t...

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1.0 - 3.0 years

8 - 13 Lacs

Mumbai

Work from Office

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Surat. The ideal candidate will have 1-3 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Supervis...

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1.0 - 6.0 years

8 - 13 Lacs

Mumbai

Work from Office

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Lucknow. The ideal candidate will have 1 to 6 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Sup...

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2.0 - 5.0 years

8 - 13 Lacs

Hubli

Work from Office

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Hubli. The ideal candidate will have 2-5 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Supervis...

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2.0 - 7.0 years

9 - 13 Lacs

Vijayapura

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We are looking for a highly motivated and results-driven Customer Sales Executive to join our team in Hubli. The ideal candidate will have 2 to 7 years of experience in sales, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products with the guidance of the Supervisor/Man...

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2.0 - 5.0 years

8 - 13 Lacs

Mumbai

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We are looking for a highly skilled and experienced Customer Service Executive to join our team in Raipur. The ideal candidate will have 2-5 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products under the guidance of the Supervi...

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2.0 - 7.0 years

8 - 13 Lacs

Mumbai

Work from Office

We are looking for a highly skilled and experienced Customer Service Executive to join our team in Bhavnagar. The ideal candidate will have 2 to 7 years of experience in customer service, preferably in the banking or financial services industry. Roles and Responsibility Perform tasks under the guidance of the Supervisor/Manager. Identify potential business customers with the help of the Supervisor/Manager. Collect and validate customer documents according to organizational norms. Log cases in the system as per SOP and follow the disbursement process. Fulfill the sanction ratio as per organizational requirements. Meet customer needs and cross-sell multiple products with the guidance of the Su...

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