3208 Regulatory Affairs Jobs - Page 35

ITI Fresher - Coating Operator RA - 4 to 6 Years ECTD Experience Compulsory R&D - Pharma Factory - 5 TO 10 YR - Male / Female Send CV on sdpbharuch@gmail.com with Subject: Formulation Panvel Share with Friends No Job Charges Required Candidate profile Interview Venue: SDP HR SOLUTION 611, Golden Square Beside DMART Near ABC Circle Bholav, Bharuch - 392001 No Interview & Joining Charges Share with your Friends Bring Your Friends along with You Perks and benefits Transportation, Canteen, Medical, ESIC

Mendine Pharmaceuticals Pvt. Ltd. operating with it's glorified journey of eight decades since 1937 (the then Mendine Pharmaceutical Works) in India with a stretch of it's business network in Eastern & North Eastern India and part of Eastern U.P. Our horizon of expertise expands from cutting edge allopathic to age-old traditions of India the Ayurveda Drugs. We have an ISO:9001:2015, WHO GMP certified Manufacturing, Research and Development set-up of our own with a wide range of Pharmaceutical, Nutraceutical and Food Supplement Products. We have also an SBU (Strategic Business Unit) viz., Mendine Lifecare Products Pvt. Ltd. - which focuses on ethical products promotion. We, at Mendine , alway...

Candidate should be M.Pharmacy with 18-20 years of experience in Regulatory Affairs department from a reputed formulations manufacturing Industry. Regulatory Strategy and Compliance: Develop and implement regulatory strategies for product formulations to ensure compliance with all applicable regulations and guidelines. Stay updated with changes in regulatory environments and proactively assess their impact on product formulations. Regulatory Submissions: Oversee the preparation, review, and submission of regulatory documents, including INDs, NDAs, ANDAs, CTDs, and other regulatory filings. Ensure timely submissions and approvals by regulatory authorities such as FDA, EMA, and other global ag...

Responsible for implementing CMC regulatory strategies for assigned products in accordance with global regulations and guidances; and is responsible for the preparation and submission of CMC dossiers for pipeline and commercial products. Accountable for the delivery of regulatory milestones for less complex projects through the product lifecycle. Participate in the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for smaller-scoped projects. Execution of CMC documentation including IND/CTA, NDA/BLA/MAA, post approval supplements, annual reports, registration renewals and responses to health authority questions per established business proces...

Responsibilities: Technical Document Preparation: Lead the preparation, review, and submission of Technical documents/Dossiers (CTD/ACTD) for both Regulatory and Non-Regulatory Markets. eCTD Publishing: Proficiently handle the electronic regulatory submissions (eCTD), ensuring accuracy and compliance with regulatory standards. Submission Build Activities: Execute submission build activities, including creating inter-document links, conducting quality checks, validating compiled submissions, and ensuring timely dispatch. Collaboration with RA - Ops Team: Coordinate and engage with the Regulatory Affairs Operations team to facilitate on-time submissions and publishing tasks. Manufacturing Docu...

Education: Bachelors Degree in Life Sciences or related field Markets: US/UK/EU/ROW Job Summary: We are seeking a detail-oriented and proactive Associate - Regulatory Affairs (RA) Publishing with 1-3 years of experience in regulatory submissions across global markets including the US, UK, EU, and ROW (Rest of World). The ideal candidate will have a background in Life Sciences and possess hands-on experience with eCTD/aCTD submissions. This role is crucial for facilitating on-time submissions, executing submission build activities, and ensuring compliance with regulatory requirements. Key Responsibilities: Prepare, review, and compile regulatory submissions in eCTD/aCTD formats for various ma...

Collaborate with stakeholders to develop and update processes and standards that will drive greater effectiveness and efficiencies globally Ensure stakeholders are informed and understand upcoming system and process changes that impact their business including value added. Collaborate with training manager to ensure training needs of end users are met. Oversee and participate in testing, validation of systems and processes as needed Monitor applicable regulatory requirements; assure compliance with Baxter and external standards May enter data into system or run data reports as needed SME in areas such as RIM-Veeva Vault, CCDS, XEVMPD/IDMP and Regulatory information quality management Maintai...

We are looking for a highly motivated and experienced Business Executive to join our team at Eris Lifesciences Limited, a leading biotechnology company in the pharmaceutical industry. The ideal candidate will have a strong background in business development and management, with excellent communication and interpersonal skills. Roles and Responsibility Develop and implement effective business strategies to achieve organizational goals. Build and maintain strong relationships with clients, partners, and stakeholders. Conduct market research and analyze industry trends to identify new business opportunities. Collaborate with cross-functional teams to develop and launch new products and services...

We are looking for a highly motivated and experienced Business Executive to join our team at Eris Lifesciences Limited, a leading biotechnology company in the pharmaceutical industry. The ideal candidate will have a strong background in business development and management, with excellent communication and interpersonal skills. Roles and Responsibility Develop and implement effective business strategies to achieve organizational goals. Build and maintain strong relationships with clients, partners, and stakeholders. Conduct market research and analyze industry trends to identify new business opportunities. Collaborate with cross-functional teams to develop and launch new products and services...

Purpose of the Job: To provide regulatory support to customers, ensuring product compliance, quality, and stewardship. The role involves addressing customer queries, monitoring global regulations, and maintaining compliance for the products. It aims to enhance product value, ensure safety, and drive business growth while upholding quality standards. Primary Responsibilities: 1. Regulatory Compliance Working on REACH registrations. Registration /pre- registration/notification of chemicals in various countries as per regulations Example: REACH (EU, Korea, Turkey, Eurasia, and many other countries) SDS Authoring: Preparation and amendment of Safety data Sheet- in different formats GHS and UN co...

Number of officials required: 02 (Two) 1) Define Grade & Level in the Hierarchy: Coordinator 2) Job Type: Contractual Location Panchkula, Hisar (Haryana) Role & responsibilities Familiarity with DISCOM functioning, regulatory processes, and technical standards Coordinate with DISCOM officials at various levels Coordination with utility officials, supporting grid integration Address operational issues, and drive demand aggregation Implementation support, scheme facilitation, vendor engagement, and field-level tracking Support awareness programs and capacity-building workshops Preparation of Project Reports, MIS and other related documents etc. Strong technical, analytical, and coordination sk...

Number of officials required: 01 (One) 1) Define Grade & Level in the Hierarchy: Team Leader 2) Job Type: Contractual 3) Location Panchkula (Haryana) Role & responsibilities 1. Job Requirements: Lead the State Project Management Unit (PMU) Understanding of Indian Power Sector Demonstrated Experience in Renewable Energy Program Implementation Liaison with Energy Departments, DISCOMs Responsible for aligning program activities with State-level policies Facilitate high-level coordination across stakeholders, and support administrative and regulatory processes Ensure timely reporting to Central/ State authorities, including MIS updates, progress reports, and policy feedback Facilitate alignment ...

Role & responsibilities We are seeking a skilled and experienced In-House Counsel to join our legal team, specializing in electricity law, regulatory affairs, commercial litigation and commercial contracts. The ideal candidate will have a strong background in handling electricity-related court cases, power purchase agreements (PPAs), co-generation power plant matters, commercial contracts and dispute resolution involving vendors, contractors, and service providers in the manufacturing industries. Preferred candidate profile Draft, review, and negotiate Power Purchase Agreements (PPAs) and other electricity sector-related contracts, including commercial agreements, engineering and procurement...

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

Preparation of DMFs for different markets in CTD and eCTD formats. Coordination with cross-functional dept to manage the documents. Supporting marketing team & QC/QA/R&D in various capacity. Preparation of Declarations and other supporting docs. Required Candidate profile Candidate from Pharma - API industry and should have 8+ Years of Experience in Regulatory Affairs. Perks and benefits Transport Canteen PF Health Insurance

Description We are seeking a skilled Legal Advisor to join our team in Indore. The ideal candidate will provide expert legal guidance to our organization, ensuring compliance with laws and regulations while supporting our business objectives. Responsibilities Provide legal advice and support to the organization on various legal matters including contracts, compliance, and corporate governance. Draft, review, and negotiate contracts and legal documents related to SDM office and Collector Office. Conduct legal research and analysis to support the organization's objectives. Assist in managing litigation and dispute resolution processes. Ensure compliance with relevant laws and regulations. Coll...

Concept Medical is a leading developer and manufacturer of innovative medical devices specializing in interventional cardiology and radiology. Your role as a Regulatory Specialist will involve ensuring that our products comply with both local and international regulatory standards such as CDSCO, ISO, and FDA. Your expertise will be crucial in maintaining the highest levels of safety and efficacy for our stents and balloon catheters. Key Responsibilities: - Develop regulatory strategies for new and existing products to meet compliance requirements. - Ensure adherence to local and international regulations including CDSCO, ISO, and FDA. - Prepare and submit regulatory documentation and filings...

Role & responsibilities 1. IPR patent evaluation 2. Selection of route of synthesis with costing. 3. Well know about updated guideline of Nitrosamine and GTI. 4. Expert in multi-step organic synthesis 5. Expertise in plant equipment selection, product / process stabilization 6. TTD preparation 7. Expertise in characterization 8. Expertise in Impurity synthesis 9. Documentation required for cross functional team.

As a part of Jubilant Generics (JGL), you will be contributing to a global integrated pharmaceutical company that offers a diverse range of products and services worldwide. With a focus on Specialty Pharmaceuticals and Generics & APIs, you will play a crucial role in the Research & Development and manufacturing facilities located in Noida, Mysore, Karnataka, and Roorkee, Uttarakhand. Key Responsibilities: - Contribute to Research & Development activities for the development of new products in API, Solid Dosage Formulations, Sterile Injectable, Semi-Solids Ointments, Creams, and Liquids. - Support manufacturing units in Mysore and Roorkee for APIs and Dosage manufacturing. - Participate in BA...

About The Role Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with AML and Fraud mgmt experience.Understand & implement laws, and regulations designed to stop the practice of generating income through illegal actions during transfer of funds. Anti Money Laundering law covers limited number of transactions and criminal behaviors to prevent terrorist financing an...

Role & responsibilities Nitrosamine and regulatory query support Conduct nitrosamine risk assessments for APIs, excipients, packaging components, and finished drug products. Evaluate manufacturing processes, raw materials, and excipients for nitrosamine risk. Review current regulatory guidelines (ICH M7, EMA, USFDA, CDSCO, WHO, and other ROW countries) and apply them in assessments. Prepare risk assessment and justification reports for internal and regulatory submission. Work with Analytical Development, Quality Assurance, Regulatory Affairs, and Formulation teams to collect and interpret required data. Support confirmatory testing strategies and assist in root cause investigations if nitros...

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Analyst Qualifications: Any Graduation Years of Experience: 3 to 5 years What would you do? Help clients transform their compliance function from reactive to proactive through an intelligent compliance operating model powered by data, intelligent technologies and talentLooking for someone with AML and Fraud mgmt experience.Understand & implement laws, and regulations designed to stop the practice of generating income through illegal actions during transfer of funds. Anti Money Laundering law covers limited number of transactions and criminal behaviors to prevent terrorist financing and money launderin...

Job Description Summary Join GE HealthCare as a Lead Specialist in Regulatory Affairs and play a pivotal role in shaping the future of medical imaging. This global leadership position offers the opportunity to drive regulatory strategies and lead cross-functional teams to bring innovative X-ray imaging products to market. Be part of a dynamic environment where your expertise will directly impact patient care and healthcare outcomes worldwide. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice ...

About The Role Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years What would you do? Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and r...

Skill required: Regulatory Services - Life Sciences Regulatory Operations Designation: LifeScience Regulatory Svs Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture 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 than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Scienc...