2122 Regulatory Affairs Jobs - Page 34

Regulatory Affairs Associate II Job Details | Teva Pharmaceuticals Find a Career With Purpose at Teva Search by Postal Code Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Regulatory Affairs Associate II Navi Mumbai, India, 400706 Who we are The opportunity The RA Associate II is responsible for preparing and revising high-quality US Gx labeling documents submitted under an ANDA and/or 505(b)(2), as required. This role ensures compliance with federal regulations, guidance documents, and internal procedures while meeting deadlines aligned with company objectives. The candidate must demonstrate the ability to work with minimal supervision and pos...

Mgr RA EU Generics Labeling Job Details | Teva Pharmaceuticals Find a Career With Purpose at Teva Search by Postal Code Area of Interest Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Mgr RA EU Generics Labeling Jul 18, 2025 Bangalore, India, 560064 Who we are The opportunity Ensure the pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products. Provide internal pharmaceutical and medical expertise to address internal and authority-related inquiries and resolve labeling issues. Ensure regulatory compliance for all ma...

We are looking for a skilled Assistant Manager to join our Accounting and Reporting consulting team at Uniqus Consultech. The ideal candidate will have 2-7 years of experience in accounting and reporting, with excellent analytical and problem-solving skills. Roles and Responsibility Manage and oversee the preparation of financial reports and statements. Develop and implement effective accounting procedures and policies. Analyze financial data to identify trends and areas for improvement. Collaborate with cross-functional teams to achieve business objectives. Ensure compliance with regulatory requirements and industry standards. Provide expert advice on accounting and reporting matters to cli...

Elite Overseas Education Consultant is looking for Europe Counselor to join our dynamic team and embark on a rewarding career journeyDeveloping and implement an all-encompassing counseling plan.Conduct group or individual counseling sessions.Excellent communication skills and high emotional intelligence abilitiesExcellent problem-solving and critical thinking skills

Regulatory Monitoring & Analysis: Continuously monitor, track, and analyze new and evolving policies, regulations, rules, tariff orders, grid codes, and standards issued by central (e.g., MoP, MNRE, CEA, CERC) and state-level authorities. Required Candidate profile • Permits, Licenses & Approvals Management (Project Lifecycle): Manage the end-to-end process of obtaining all required licenses, permits, and approvals for solar, wind, and hybrid power projects.

1. Connect top specialist doctors across India. 2. Focus on Phase 4 clinical trials and Post-Marketing Surveillance (PMS) 3. Ensure compliance and registration for clinical trials 4. Conduct medical survey for research & strategy purpose

Role & responsibilities Asst Manager / Sr. Executive - Regulatory DRA DEPT- Europe Market @ Pharma Formulation -PUNE City. Person will be responsible for DRA function for Pharma Formulation for Advanced Markets / EU The candidate should be conversant with preparing dossiers for Finished Formulations for EU. Preferred candidate profile Honest, Hard Working. Growth Mindset (Important). Good Communications Skills. Relevant Experience in Pharma Only Candidate with Relevant Experience may apply. We also encourage rightful candidates to write directly to us to "info@vekocare.com" with a proper covering note.

As a Senior Chemist in the Pharma Manufacturing Industry located in Vatva, Ahmedabad, your role will involve utilizing your M.Sc. in Organic Chemistry and 5 to 8 years of experience in API / Intermediates manufacturing within the pharmaceutical sector. Your responsibilities will include hands-on experience in the synthesis of APIs and intermediates, conducting literature searches using platforms such as SciFinder, Chemical Abstracts, Free Patent Online, and Journals. You will be involved in feasibility studies, route selection for synthesis, multi-step synthesis, yield improvement, and cost reduction strategies. Additionally, you will be responsible for tasks such as extraction, purification...

Company: Leeford Healthcare Ltd. https://www.leeford.in/ Position: Asst. Manager / Manager - Drug Regulatory Affairs (Domestic Market) Job location: Ludhiana Experience : 6 yrs above Job Profile: Review of labels of Drugs and ensuring their full compliance with the applicable Rules and Regulations. Handling and responding to all the product specific queries. Performing Root cause and analysis and preparing replies to the show cause notices Ensuring overall compliance with domestic regulatory requirements. Co-ordination with respective departments. Maintaining familiarity with company product ranges. Keeping up to date with changes in regulatory legislation and guidelines. Ensuring that quali...

Company: Leeford Healthcare Ltd. https://www.leeford.in/ Position: Asst. Manager / Manager - Drug Regulatory Affairs (Domestic Market) Job location: Ludhiana Experience : 6 yrs above Job Profile: Review of labels of Drugs and ensuring their full compliance with the applicable Rules and Regulations. Handling and responding to all the product specific queries. Performing Root cause and analysis and preparing replies to the show cause notices Ensuring overall compliance with domestic regulatory requirements. Co-ordination with respective departments. Maintaining familiarity with company product ranges. Keeping up to date with changes in regulatory legislation and guidelines. Ensuring that quali...

Company: Leeford Healthcare Ltd. https://www.leeford.in/ Position: Asst. Manager / Manager - Drug Regulatory Affairs (Domestic Market) Job location: Ludhiana Experience : 6 yrs above Job Profile: Review of labels of Drugs and ensuring their full compliance with the applicable Rules and Regulations. Handling and responding to all the product specific queries. Performing Root cause and analysis and preparing replies to the show cause notices Ensuring overall compliance with domestic regulatory requirements. Co-ordination with respective departments. Maintaining familiarity with company product ranges. Keeping up to date with changes in regulatory legislation and guidelines. Ensuring that quali...

Role Summary: The purpose of this role is to support all business development activities in RE projects and play an integral role in building MWs. This includes handling regulatory affairs, tender preparation & submission, obtaining connectivity at ISTS / STU level, coordinating with tendering agencies / CTU / PGCIL / MNRE / RE associations How You Will Make an Impact: Work towards project opportunities identification and assessments, regulatory feasibility and approvals. Effectively coordinate within internal teams (Technical, Financial, Projects, Procurement and Legal) and other stakeholders to make the potential project ready for investment Tender participation including preparation of bi...

Job Description To coordinate with research and Development / Plant for technology transfer execution of exhibit batches, launch products and validation batches. To coordinate with purchase department for availability of all raw materials to ensure smooth execution of trial bathes, scale up batches, Exhibit batches & Pre-validation batches. Design and approval of documents related to manufacturing of scale up batches, exhibit batches, validation batches and commercial batches and support to execution. To conduct the process validation of the product. To support site-regulatory affairs in timely filing of exhibit products/ Variation batches. To assist plant in regulatory inspection of custome...

About the role We are seeking a dynamic and strategic Corporate Affairs Manager to oversee and manage the companies interactions with internal and external stakeholders, including regulatory bodies, government agencies, industry groups, media, and the public. This role is critical in shaping our corporate image, ensuring compliance with regulations, managing public relations, and supporting our strategic communication initiatives. Responsibilities 1. Government and Regulatory Affairs: • Serve as the primary liaison between the company and government authorities, regulatory, agencies and industry associations. • Monitor, interpret, and communicate regulatory and legislative developments affec...

Are you the person who can decode a CERC order in the morning and help structure a PPA in the afternoon? We're looking for a sharp mind to navigate India's complex energy regulations and drive our business forward. Your mission: Transform regulatory challenges into commercial opportunities. You will be our expert on policy advocacy, grid codes, and green access rules, using that knowledge to develop new solar/wind projects and secure key partnerships. You are: A master of the Indian renewable energy landscape, with proven experience in both regulatory affairs and business development. You have a track record of turning policy shifts into profitable, grid-connected projects. Think youre the r...

Urgent Job Opening Quality Assurance, Quality Control, Clinical Research , Regulatory Affairs, Medical Record Summarization , Medical Claims , Medical Officer, Medical Billing , Pharmacist, ADL, ARD, FRD, CDM, Production, R&D , Lab Technician

Role & responsibilities Government Liaison - Maintain effective liaison with government departments such as Pollution Control Board, Veterinary Department, Labour Department, APEDA, and Boiler Department.- Build and sustain strong relationships with officials to ensure smooth operations and compliance. Administrative Coordination - Liaise with administrative bodies, including the District Collectors Office, Police Departments, and Food Safety Department.- Represent the companys interests in meetings, inspections, and other official engagements. License and Compliance Management - Oversee the acquisition and renewal of all licenses required for operating the meat processing unit.- Ensure comp...

Mega Virtual drive for Compliance Engineer for Bangalore location Experience : 5 - 10 Years Work Location : Bangalore No of Positions : 5 Roles & Responsibilities: BE/ ME in Mechanical Engineering with 5 - 10 years of experience in the product compliance with various product regulatory or certification agencies. Should have knowledge about the necessity of international certifications like IEC, IECEx, etc and other country regulatory certification like CSA, UL, TUV, Intertek, CE marking, etc. Basic knowledge in the various directives for the EU requirements for the CE marking. Should have basic design Knowledge in the Pressure equipments like Compressors and its accessories. Basic Knowledge ...

As a highly experienced professional in the field of environmental services, you will be responsible for defining and managing the global product strategy, roadmap, and lifecycle for carbon and plastic credit services. Your role will involve developing service guidelines, tools, and technical content to ensure consistent, scalable, and credible delivery. Identifying and pursuing innovation and market expansion opportunities, including digital solutions, will be a key aspect of your responsibilities. In this position, you will provide support to regional teams by sharing your technical expertise, offering training, and engaging with clients during pre-sales activities. Collaboration with cert...

The role of Business Development in Mumbai, India involves various responsibilities to enhance partnerships and product offerings. You will be tasked with scouting new partners/products and recommending products for consideration by senior and executive leadership. Developing comprehensive business cases across different product categories for the US and Canadian markets will be a key focus, including Institutional, Retail, and OTC segments. Your responsibilities will also include creating presentation materials for team and leadership meetings, supporting deal closure activities, assisting in drafting non-binding term sheets, and participating in agreement negotiations. You will play a cruc...

As an Assistant Manager/Manager in Regulatory Affairs with 7-11 years of experience, you will report to the Head of Regulatory Affairs and be responsible for handling regulatory activities for the Canadian market. Your primary focus will be to develop regulatory strategies for submissions, assess changes, and manage the product life-cycle across various dosage forms. You will also be involved in compiling New Drug Submissions (NDS) and Abbreviated New Drug Submissions (ANDS), as well as conducting module-wise document reviews. Your role will encompass reviewing documents and artworks to ensure compliance with eCTD (electronic Common Technical Document) guidelines, as well as overseeing chang...

The Regulatory Affairs Senior Associate role involves being responsible for the preparation, compilation, evaluation, and submission of ANDAs & Amendments to USFDA. This position also entails handling deficiencies and ensuring the timely submission of responses to the agency. Your main responsibilities will include coordinating with cross-functional teams and stakeholders such as R&D, Quality, manufacturing, SCM, IP, and PM, along with vendors when necessary. You will be tasked with evaluating documents in accordance with current regulatory requirements. Additionally, you will need to review various documents including Product Development Reports, Batch Records, Specifications, Analytical Pr...

This is a full-time on-site role for a Manager / Deputy Manager Regulatory Affairs located in Vadodara. As the Manager / Deputy Manager, your responsibilities will include developing and implementing regulatory strategies, ensuring compliance with regulatory requirements, preparing and submitting regulatory documents, and maintaining regulatory files. Your role will involve interacting with regulatory agencies, managing timelines, and ensuring that all products meet regulatory standards. Your key responsibilities will be to develop and direct global regulatory strategies for clinical, non-clinical, and CMC aspects. You will lead the preparation, review, and approval of submission documents f...

As a member of the Groww Mutual Fund team, you will be part of an organization dedicated to providing mutual fund schemes tailored to meet the diverse needs and objectives of our investors. Anchored by principles of simplicity, transparency, long-term wealth creation, and customer focus, we pride ourselves on identifying investment opportunities that offer growth potential with solid fundamentals. Our mission revolves around creating steady, long-term wealth for our investors by uncovering promising opportunities and designing innovative schemes. We prioritize simplicity and transparency in our communication, ensuring that our investors can make informed decisions with clarity. Consistency i...

Role & responsibilities Liaison with Food & Drugs Control Administration, Gandhinagar/circle offices/CDSCO for various applications including but not limited to Product Permissions for manufacturing COPPs Various certificates for tender (FSC, Performance certificate, Non-conviction certificate) Inspections for WHO GMP/Schedule M GMP certification Technical persons approval Technical person application verification. Liaison with CDSCO, West Zone, Form 29 Export licenses Loan license Manufacturing licence renewal for all plants Wholesale licences Submission of commercial batches to CDL Kasauli for testing Submission of quarterly returns to NCB/CBN Handling NSQs Experience in submissions throug...