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13.0 - 23.0 years
14 - 24 Lacs
Hyderabad
Work from Office
Urgent Requirement For Regulatory Affairs - FML Department in FML Division - MSN Laboratories, R&D Center Regulatory Affairs FML Department in FML Division , Job Description: ( Regulatory Affairs - FML Division ) Should have minimum of 13 to 23 years of experience in FML Regulatory Affairs Job Title: Deputy Manager / Manager / Senior Manager / AGM Experience: 13 to 23 years in FML RA field Candidates Only. Education: B Pharm \ MSc \ M Pharm Department : Regulatory Affairs - FML Markets : China, Europe, Australia, US, ROW Key Skills Regulatory Guidelines Knowledge, Documentation, Problem-solving, Strong Communication, Collaboration, Organization Skills Role & responsibilities International Pr...
Posted 3 months ago
0.0 - 4.0 years
2 - 7 Lacs
Navi Mumbai, Pune
Work from Office
Immediate Job Openings for our Pharma Clients Job Profile Quality Assurance, Quality Control , CRA , R & D , Pharmacist , Medical Claims , Medical Record summarization , Medical Billing , Medical Writer , BDM , CDM , RA Production ,
Posted 3 months ago
6.0 - 11.0 years
18 - 30 Lacs
Noida
Hybrid
ProgrammesProgram Manager, ICX: Description: Adobe's ICX team is seeking a passionate and energetic Program Manager to drive key initiatives and execute strategic and operational objectives. ICX (Integrated Customer Experience) combines frontline Sales and Support for Adobe, serving as the first point of contact for customers seeking assistance, inquiries, or opportunities to expand their footprint. This role focuses on all customers, from consumers to medium-sized businesses. We need someone with creative ideas, critical thinking, and a strong appetite for execution. Exemplary communication skills and the ability to influence are essential. The ideal candidate will excel in driving key oper...
Posted 3 months ago
1.0 - 5.0 years
1 - 3 Lacs
Vijayawada, Eluru, Bhimavaram
Work from Office
We are looking for a highly skilled and experienced Receivable Executive to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 1-5 years of experience in the BFSI industry. Roles and Responsibility Manage and maintain accurate records of receivables, including invoices, payments, and outstanding balances. Develop and implement effective strategies to improve cash flow and reduce delinquencies. Collaborate with cross-functional teams to resolve customer complaints and disputes. Analyze financial data to identify trends and areas for improvement in receivable management. Ensure compliance with regulatory requirements and internal policies related to receivables. Pro...
Posted 3 months ago
2.0 - 7.0 years
1 - 5 Lacs
Hubli, Thrissur
Work from Office
We are looking for a skilled Branch Receivable Manager to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 5-10 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee the branch's receivable portfolio, ensuring timely payments and minimizing bad debts. Develop and implement strategies to improve cash flow and reduce receivables. Collaborate with cross-functional teams to resolve customer complaints and issues. Analyze financial data to identify trends and areas for improvement in receivables management. Ensure compliance with regulatory requirements and internal policies related to receivables. Lead and motivate a team of professio...
Posted 3 months ago
1.0 - 3.0 years
8 - 12 Lacs
Pune, Gurugram
Work from Office
Job Description: Role Interact with Client Stakeholders and provide highly integrated research support. This will include pre-investment ESG due diligence and adhoc ESG research, including sustainability reports, sector/regulation writeups, preparing slides, maintaining backups, etc. Assist in project planning and completion and coordinate internally to deliver the final output Update and maintain client’s proprietary / ESG database Showcase positive attitude and ability to work with tight deadlines with minimum guidance Prior knowledge of ESG/Sustainability and Credit research is a plus Guide and mentor junior team member(s) Skills: Ability to map companies by sector and conduct diligence b...
Posted 3 months ago
6.0 - 8.0 years
8 - 11 Lacs
Hyderabad
Work from Office
The Senior Associate, Global Submission Management – International, will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the international (ex-US and Canada) context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management ...
Posted 3 months ago
5.0 - 8.0 years
7 - 10 Lacs
Hyderabad
Work from Office
What you will do Let’s do this. Let’s change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you will interface with the Amgen Global, Site...
Posted 3 months ago
5.0 - 10.0 years
7 - 14 Lacs
Hyderabad/Secunderabad
Work from Office
Roles and Responsibilities Should Have Formulation Experience. 1. Responsible for product registration in ROW (AFRICA, ANZ, ASIA, LATAM, CIS &, MENA). 2. Responsible and involving in the regulatory audits and coordinating with the auditors/customers. 3. Preparation, compilation and review of dossiers for RoW region in CTD /country specific format. 4. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. 5. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. 6...
Posted 3 months ago
10.0 - 15.0 years
20 - 25 Lacs
Vapi, Ahmedabad, Mumbai (All Areas)
Work from Office
Continuously update knowledge of relevant regulations, guidelines, and industry standards. Ensure that products and processes adhere to all applicable regulations throughout the lifecycle, from development to post-market surveillanc Required Candidate profile Prepare, review, and submit regulatory documentation, including applications, reports, and amendments, to regulatory agencies. Prepare for and participate in regulatory audits.
Posted 3 months ago
2.0 - 4.0 years
8 - 12 Lacs
Mumbai
Work from Office
Dossier Power House
Posted 3 months ago
0.0 - 3.0 years
0 Lacs
Mumbai Suburban
Work from Office
Responsibilities: * Prepare documentation according to ISO 13485 standards. * Ensure compliance with EU MDR, US FDA & CDSCO guidelines. * Maintain regulatory documentation * Internal Audits
Posted 3 months ago
2.0 - 7.0 years
5 - 8 Lacs
Ahmedabad
Work from Office
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 highly specialized 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 manag...
Posted 3 months ago
4.0 - 8.0 years
4 - 8 Lacs
Kadi, Ahmedabad
Work from Office
Key responsibilities Prepare and submit applications via the SUGAM portal (Form 41 & 46) to relevant authorities (DCGI, IVRI, Krishibhavan, and DAHD) for veterinary products. Compile, review, and prepare CTD/eCTD dossiers for veterinary vaccines and APIs in compliance with CDSCO and international guidelines. Handle end-to-end veterinary product registration, including new applications, renewals, updates, and query responses. Track application status, follow up with authorities, and ensure timely responses to regulatory queries and deficiencies. Support audits by CDSCO and other bodies; maintain organized, inspection-ready documentation and records. Review and approve product Labelling and pa...
Posted 3 months ago
3.0 - 5.0 years
3 - 5 Lacs
Bengaluru
Work from Office
We are seeking an experienced Regulatory Affairs professional to support and manage the regulatory lifecycle of oral solid dosage (OSD) products across key global markets, including the EU, USA, and RoW.
Posted 3 months ago
2.0 - 6.0 years
3 - 7 Lacs
Hyderabad
Work from Office
The Regulatory Compliance Change Assessor will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams, as well as Amgen Operations, Quality, and/or Supply Chain for specific strategies or activities that impact a product. The Change Assessor will be responsible for varying levels of product support, including global reportability assessment of single or cross-product changes, based upon their experience level. Roles & Responsibilities: Key responsibilities of the Regulatory Sr Associate include: Reviews change records to evaluate impact of the change with respect to reportability and product restrictions for any product in scope. Defines and documents the reporting an...
Posted 3 months ago
3.0 - 5.0 years
2 - 6 Lacs
Bengaluru
Work from Office
Skill required: Regulatory Services - Life Sciences Regulatory Affairs Designation: LifeScience Regulatory Svs Analyst Qualifications: Master of Pharmacy Years of Experience: 3 to 5 years About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more ...
Posted 3 months ago
3.0 - 7.0 years
3 - 7 Lacs
Mumbai
Work from Office
IVL India Environmental RD is looking for Quality Expert to join our dynamic team and embark on a rewarding career journey. Develop and implement quality assurance policies and procedures. Conduct quality audits and inspections. Analyze data to identify areas for improvement. Provide training on quality standards and processes. Ensure compliance with regulatory requirements.
Posted 3 months ago
3.0 - 8.0 years
25 - 30 Lacs
Ahmedabad
Work from Office
Wte Infra Projects Pvt Ltd 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 p...
Posted 3 months ago
2.0 - 5.0 years
2 - 5 Lacs
Ahmedabad
Work from Office
To prepare Standard Operating Procedures of all departments. To review batch manufacturing records protocols and reports of all Active Pharmaceuticals Ingredients and Intermediates to support DMF / FILING. Follow quality assurance systems as per cGMP guidelines. To ensure that all manufacturing operations at the location comply with ICH Q7 system, documentation and records. To follow a system for releasing or rejecting all APIs. To follow up a system for releasing or rejecting intermediates for use outside the control of the manufacturing company. To follow a system to release or reject RM, Intermediates, packing and labeling materials. To perform product quality review. To prepare product l...
Posted 3 months ago
1.0 - 4.0 years
3 - 6 Lacs
Mumbai, Tarapur, Ahmedabad
Work from Office
Kamla Homes is looking for Officer- RA to join our dynamic team and embark on a rewarding career journey Prepare regulatory submissions for product approvals Ensure compliance with domestic and global regulations Monitor regulatory changes and update dossiers Coordinate with QA and production for alignment
Posted 3 months ago
8.0 - 10.0 years
10 - 12 Lacs
Hyderabad
Work from Office
Apollo Pipes Ltd 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 an...
Posted 3 months ago
3.0 - 6.0 years
10 - 20 Lacs
Hyderabad
Work from Office
Preparation & review of US ANDAs/ 505(b)(2)/EU/ Canada dossiers for Parenteral products as per regulatory requirements. Preparation & review of deficiency responses, regulatory strategy note, controlled correspondences, Briefing books, labeling, artworks and ScA meeting packages. Coordinate with internal stake holders (R&D, AR&D, SCM, FTO, CTO etc) and external counterparts (CMO & CRO) to review regulatory documents and proposals and provide strategic inputs. Identify all open issues at product development, ANDA filing and deficiency responses in consultation with team lead/RA vertical head. Provide support to commercial launch team w.r.t review progress and evaluate changes proposed for com...
Posted 3 months ago
3.0 - 8.0 years
5 - 10 Lacs
Pune
Work from Office
Providing insights on industry and market developments, including policy and regulatory updates to advocate for favourable outcomes. Analysis of Regulations, Guidelines, Policies, Important order, etc. to derive meaningful insights & actionable for higher management. Support in Policy Advocacy, legal & regulatory on filing petitions with appropriate authority. Support in review of bidding, bid documents, RFS & PPA. Support in creation of Memorandums of Understanding (MOU) with government bodies, ensuring alignment with legal and strategic frameworks. Supporting business development and project expansion, ensuring alignment with ENGIEs strategy and objectives. Building positive relationships ...
Posted 3 months ago
8.0 - 12.0 years
10 - 14 Lacs
Hyderabad
Work from Office
About The Role What you will do Let’s do this. Let’s change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by: Driving continuous improvement of processes and tools Ensuring awareness of processes across the organization; and Shaping the training strategy across the organization The Manager in SPPM will be responsible for developing, maintaining, improving, and driving consistency across the practices and procedures related to CMC processes. Job responsibilities of the SPPM Man...
Posted 3 months ago
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