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1.0 - 3.0 years
0 - 3 Lacs
noida
Work from Office
1. Drug Regulatory Affairs - Job description Prepare CTD, ACTD Dossiers and file regulatory submissions Perform assessments of new or revised products Manage complaint documentation (including investigation and closure) Respond to inquiries from regulatory bodies Should be technically well versed with requirements for Medicines with fare knowledge about Food supplement, medicines To Coordinate with relevant department for arranging documents To prepare / compile dossier for allocated products / countries To coordinate with account department for handling Local FDA fees / transfer of amount for legalization etc To coordinate with courier agency for dispatches of dossier /samples To make timel...
Posted 1 month ago
17.0 - 27.0 years
20 - 30 Lacs
nagpur
Work from Office
Job Summary: We are looking for an experienced and strategic Regulatory Affairs leader to head our Regulatory function. The ideal candidate will oversee all regulatory submission activities, ensure timely approvals, maintain compliance with evolving global health authority requirements, and provide expert regulatory guidance for new and existing pharmaceutical products across ROW & regulated markets. Key Responsibilities Regulatory Strategy & Compliance: • Coordinate with agents, partners, and MOHs to define submission strategies. • Prepare internal strategy documents and lead regulatory discussions for new products. Dossier Management & Submissions: • Manage CTD/ACTD/eCTD submissions for ne...
Posted 1 month ago
3.0 - 5.0 years
3 - 4 Lacs
navi mumbai
Work from Office
Role & responsibilities 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. Preparation and submission of ...
Posted 1 month ago
10.0 - 15.0 years
10 - 15 Lacs
hyderabad
Work from Office
Responsibilities: * Exp on procedure of application of new Drug * Manage COPPs, GMP, GLP compliance & SUGAM portal maintenance * Oversee license renewals, dossier reviews & NIB submissions * Trademark License & Coordinate with Drug Control Authority
Posted 1 month ago
14.0 - 18.0 years
11 - 21 Lacs
bengaluru
Work from Office
We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates, partners, and health authorities to ensure timely approvals and post-approval compliance. Key Responsibilities: • Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for biosimilars in Emerging Markets. • Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, CIS countries, ASEAN, LATA...
Posted 1 month ago
3.0 - 8.0 years
2 - 5 Lacs
visakhapatnam, hyderabad
Work from Office
Diploma/Bachelor’s degree in Electronics, Telecommunications, Electrical, or Civil Engineering. 4–8 years of experience in fiber deployment, with at least 2–3 years in a supervisory/cluster-level role. Mail - hr.ta@depl.co.in Andhra Pradesh
Posted 1 month ago
5.0 - 10.0 years
3 - 8 Lacs
ahmedabad
Work from Office
Key Responsibilities Prepare, review, and submit CTD/ACTD/eCTD dossiers for international markets Develop and execute regulatory strategies for ROW, LATAM, SEA, Africa, and Pacific regions Manage product registration, renewals, variations, and post-approval compliance Ensure compliance with WHO-GMP, ICH, and country-specific regulatory guidelines Coordinate bioequivalence studies and relevant documentation Review technical files and maintain up-to-date regulatory documentation Liaise with regulatory authorities, internal departments, and external partners Mentor junior RA team members and drive process improvements Requirements B.Pharm / M.Pharm / Life Sciences background Minimum 6 years exp...
Posted 1 month ago
4.0 - 9.0 years
5 - 9 Lacs
thane
Work from Office
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 aware of new products and competition status
Posted 1 month ago
7.0 - 11.0 years
8 - 12 Lacs
pune
Work from Office
Job Description Pharma Regulatory Affairs Manager Location: Pune, Maharashtra Department: Regulatory Affairs Reports To: Head – Regulatory Affairs / Senior Leadership Job Overview We are seeking a highly skilled and experienced Pharma Regulatory Affairs Manager to ensure compliance with global regulatory requirements and to support the successful development, approval, and commercialization of pharmaceutical products. The ideal candidate will bring deep expertise in regulatory affairs, strong leadership in navigating complex regulatory landscapes, and the ability to collaborate effectively with internal teams and regulatory authorities. Key Responsibilities Develop and implement regulatory s...
Posted 1 month ago
1.0 - 7.0 years
25 - 30 Lacs
kolkata, new delhi
Work from Office
Perpetuity Capital is looking for AREA SALES MANAGER 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 companys 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 aware of new products a...
Posted 2 months ago
3.0 - 5.0 years
4 - 5 Lacs
jaipur, jaisalmer, jodhpur
Work from Office
We are looking for Right of Way (ROW) and Lead land acquisition processes for high voltage transmission projects. Handle negotiations, legal documentation, govt. clearances, and stakeholder management to ensure smooth and timely project execution.
Posted 2 months ago
5.0 - 10.0 years
4 - 5 Lacs
mumbai suburban, mumbai (all areas)
Work from Office
Role & responsibilities 1. To ensure that all required information is included in the regulatory filing. 2. To collect the documents require for dossier preparation. 3.To evaluate the country wise requirements for dossier preparation as per checklist. And compile a draft dossier as per requirements and in the format provided by the authority of the country. 4.To co-ordinate with Artwork, Purchase, QC, QA, R&D, Packaging, Licensing Department for necessary documents/data. Prepare documents for courier purpose and send the courier. 5. Keep a track of the courier to check delivery on time. Providing comments on the product, preparing and submitting a regulatory application, and working with oth...
Posted 2 months ago
5.0 - 10.0 years
20 - 27 Lacs
noida
Work from Office
Description: Power BI with Fabric Requirements: Job Duties Design, develop, and maintain Power BI reports and dashboards that provide actionable insights from assessment data Work with data provided by Organization's established ETL processes and other data sources Create and optimize data models within Power BI to ensure reports are accurate and performant Apply innovative visualization techniques to clearly communicate assessment analytics Deploy and maintain Power BI reports in a Microsoft Fabric environment Collaborate with product management to prioritize and plan necessary delivery, design improvements and performance. Collaborate with the product team and development community of prac...
Posted 2 months ago
3.0 - 6.0 years
3 - 6 Lacs
ahmedabad
Work from Office
Job Title:Sr. International Regulatory Affairs Executive/Officer Companies: Pharma Location: Ahmedabad Bodakdev Exp: 4-6 Yrs email: jobs@winstonhrservices.com Whatsapp: 7383005000 Openings: 02 Required Candidate profile Preparing & review Dossiers for registration of products in various ROW markets Legalization of FDCA documents for respective country registration Preparing, managing FSC & COPP applications for FDCA
Posted 2 months ago
14.0 - 24.0 years
0 - 0 Lacs
pune, nashik, kalyan
On-site
Role : Deputy General Manager - Sales (ROW Market) Geographies Covered : East Africa : Uganda, Ethiopia, Kenya, Tanzania, Malawi, Zambia, Zimbabwe, Nigeria, Ghana French West Africa: Ivory Coast, Benin, Senegal, Mali, Burkina Faso, Togo Company name : Medley Pharmaceutical Limited Company Profile : We are progressive WHO-GMP, MHRA UK and USFDA certified company beside approval by several other countries and one of the fastest growing amongst the top 40 pharmaceutical companies in the country as per IMS. We are currently present in about 30 countries including UK, European countries & ROW. * Working Days & Time : Monday to Saturday. 2nd & 4th Saturday Off * Flexi Time : (9.00 am 10.00 am) wit...
Posted 2 months ago
3.0 - 6.0 years
0 - 0 Lacs
ahmedabad
Work from Office
Role & responsibilities To explore in-licensing partners for RoW markets (Asia , Middle East , Africa) Project Management for RoW markets New Product identification and Portfolio management. Good knowledge of Regulatory guidelines for above markets. Commercial evaluation of the business case to make it viable to execute new business/ existing business Manage timely delivery of projects by keeping track of all internal activities. Take responsibilities for business development activities in the designated markets. Launch executions, critical order management for designated business Manage customer relationship, retain and grow existing business Sound analytical & logical skill, ability to lea...
Posted 2 months ago
2.0 - 7.0 years
3 - 8 Lacs
hyderabad
Work from Office
Regulatory Affairs Job Opportunity! Desired Experience : 3- 9 years Job Location : Genome Valley, Shameerpet, Hyderabad Preferred Industry : Vaccines / Biotech Designation: Senior Executive/ Executive Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy Job Responsibilities: Responsible for Regulatory submission to Indian NRA, Emerging Markets, Regulated Markets and World Health Organization. Experienced in handling, management and expansion of product portfolios, markets/ territories. Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC. Expertise in preparation, compilation and submission of Indian NRA applications (Eg: Form CT 10, 16, CT18, 40, 10, E...
Posted 2 months ago
3.0 - 8.0 years
0 - 1 Lacs
Bengaluru
Work from Office
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
2.0 - 5.0 years
7 - 11 Lacs
Hyderabad
Work from Office
Role Name: BI Platform Automation Engineer Job Type: Full-time About Amgen Amgen harnesses the best of biology and technology to fight the worlds toughest diseases, and make peoples lives easier, fuller and longer We discover, develop, manufacture and deliver innovative medicines to help millions of patients Amgen helped establish the biotechnology industry more than 45 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond whats known today, About The Role Role Description: The role is responsible for performance monitoring, maintenance, and reliable operation of BI Platforms, BI servers and database This role involves managing BI Ser...
Posted 3 months ago
8.0 - 10.0 years
8 - 10 Lacs
Tumkur, Chikkaballapura, Ramanagara
Work from Office
Role & responsibilities To identify, Negotiation and acquisition of cost effective and business doable properties for organization in respect of solar installations. To obtain permissions & licenses from Govt. and other authorities for the development of solar installation. Identification & negotiation for financially & technically feasible & cost saving properties with the help of RoI and other calculations. Negotiation for rental restructuring with existing property owners. Negotiation on renewal cost. To maintain healthy relationship with Govt. official, local politicians, civilians & residents to avoid unwanted resistances and agitations. To ensure smooth development of project without a...
Posted 3 months ago
5.0 - 10.0 years
3 - 6 Lacs
Andhra Pradesh
Work from Office
Role & responsibilities 1. To maintain detailed records of land acquisitions, easements, permits, agreements, and other relevant documents throughout the project lifecycle. This documentation is critical for legal compliance, project monitoring, and future maintenance. 2. To discuss with Local Farmers & resolving ROW. 3. Coordinating with Revenue Officers/ Agricultural Officers for Crop Yield Prices. 4. Discussing with Collectors/Police Deptt. for their intervention in resolving critical ROW's. 5. Handing over crop compensation cheques to eligible farmers duly taking acknowledgements. 6. Collaborate closely with other members of the project team. to ensure alignment of project goals and requ...
Posted 3 months ago
5.0 - 8.0 years
12 - 17 Lacs
Thane, Navi Mumbai, Mumbai (All Areas)
Work from Office
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...
Posted 3 months ago
5.0 - 10.0 years
6 - 10 Lacs
Kolkata
Work from Office
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...
Posted 3 months ago
4.0 - 8.0 years
5 - 9 Lacs
Dholka
Work from Office
Role : Senior Executive Qualification: M. Pharma/B. Pharma Experience : 4 to 8 Years Location : Dholka, Gujarat Responsibilities 1. Preparation and submission of registration and re-registration dossiers as per country requirements of ROW (Preferable Russia, CIS countries and WHO) 2. Arrangement for indent of Samples, Packing Material specimen, Impurities, Reference Standards as per submission requirement. 3. Query evaluation and submission with respective countries requirement within the required time frame. 4. Establish coordination with other departments like QA/QC, R&D, Marketing and Purchase for ensuring the filings and query response within time frame. 5. Post approval activities: Subm...
Posted 3 months ago
11.0 - 17.0 years
9 - 13 Lacs
Ahmedabad
Work from Office
Role & responsibilities Job Title: International Regulatory Affairs (IRA) Sr. Manager Location: Ahmedabad -HO Markets: CIS (Including EAEU), LATAM (Central and South America), Middle East, Africa, South East Asia. Key Responsibilities: 1.Prepare monthly regulatory MIS reports and present status updates, key metrics, and strategic insights to senior management. 2. Manage relationships with external regulatory consultants, in-country partners, submission vendors, and the external regulatory team to ensure timely regulatory filings and ongoing compliance. 3. Collaborate cross-functionally with Formulation, QA, QC, Packaging Development, Production, RA, PV, and BD teams for data collection, gap ...
Posted 3 months ago
 
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