Regulatory Affairs Consultant

Experience: 8 to 20 YearsLocation: Bangalore OR RemoteSkills: Regulatory Affairs, Clinical trial application, Clinical Trial Regulation, CDSCO10+ yrs relevant experience in Clinical Trial Regulatory Submissions.Experience in managing clinical trial studies, playing Regulatory Leads for Global trials, and exposure to the European market.Expertise in handling...

**Regulatory Affairs Associate** 2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. - To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including: - Submission delivery strategy - Review of documents - Analysis of...

Experience: 8 to 20 Years Location: Bangalore OR Remote Skills: Regulatory Affairs, Clinical trial application, Clinical Trial Regulation, CDSCO10+ yrs relevant experience in Clinical Trial Regulatory Submissions.Experience in managing clinical trial studies, playing Regulatory Leads for Global trials, and exposure to the European market.Expertise in...

Job Description - Regulatory Affairs AssociateYour mission, if you choose to accept, will be :ResponsibilitiesParticipate in the development of regulatory submission and approval strategy in multiple countries.Ensure compliance with FDA, ISO 13485, MDR, and other relevant regulatory requirements.Maintain awareness and understanding of new and existing...

Job Description - Regulatory Affairs AssociateYour mission, if you choose to accept, will be :ResponsibilitiesParticipate in the development of regulatory submission and approval strategy in multiple countries.Ensure compliance with FDA, ISO 13485, MDR, and other relevant regulatory requirements.Maintain awareness and understanding of new and existing...

**_Regulatory Affairs Associate _**: **Experience: RIM**: **Relevant experience in Regulatory and should be willing to work in EU Shifts (12:00 - 9.00 PM)**: - **Experience of handling RIM tools - Veeva Vault specifically.**: - **Basic Regulatory knowledge on regulations and Health Authorities.**: - **Excellent communication skills.** **Knowledge and...

**About Us**: An established player in the B2B Pharma raw material space has recently launched an exciting new E-commerce platform **- CLYZO** **Position - Regulatory Affairs Associate.** An organization with a reputed history of 10+ years in the Pharma raw material industry, dealing in excipient products is looking for Regulatory Affair Executive having...

**Internal Title**:Regulatory Affairs Professional **External Title**:Deputy General Manager **Position Summary** To perform regulatory tasks as applicable to SHPL products pertaining to regulating authorities like radiation safety related certification from Atomic Energy Regulatory Board (AERB) for Zone India (India, Bangladesh, Nepal, Sri Lanka &...

**Responsibilities**: - Work closely with Engineering team through product development process and design activities - Author/participate in the design validation and process validations, IQ, OQ, PQ. - Prepare, review risk management files and support risk management activities including hazard analysis and FMEA. - Identify relevant guidance documents,...

Title: Lead - Regulatory Affairs Date: May 10, 2024 Location: Bangalore, KA, IN We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a...

**Lab/Affiliation**:UTSAAH Lab, CPDM, Indian Institute of Science, Bangalore **Project**: Ikshana - An integrated system for adaptive stimulation treatment of urinary incontinence - (ikshanahealthcare.co.in)_ **___________________________________________________** **OPEN POSITION: Internship - Regulatory Affairs** **Desirable Qualifications**: Final year...

About Halma:Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US.Our diverse group of nearly 50 global companies specialise in market leading technologies that push the...

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

**Job Title: Regulatory Affairs Associate I** **Career Level - C** **Introduction to Role**: **Accountabilities**: As a Regulatory Affairs Associate, you will be responsible for document management, including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements. You will maintain...

Responsible for collating and compiling the dossiers for filing in different International markets like Africa, Asia, Latam, CIS & EU markets as per Relevant Regulatory guidelines of Pharmaceutical dosage forms like Tablets/Capsules/Dry syrup/Liquid syrup/Sterile Injectables (powder & liquid) /Ophthalmic/Semi solid preparations. Co-ordinating with...

**Key Accountabilities**: **Project Administration**: - Under supervision provide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumization, pagination, and formatting of reports and simple submissions. - Provide...

**Job Title - CMC RA Associate I Submission Excellence & Project Management.** **CAREER LEVEL: C** **ABOUT ASTRAZENECA** AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more...

Provide responses to regulatory agencies regarding product information or issues. - Train RA Assistant and staffs in regulatory policies or procedures. Coordinate internal discoveries and depositions with legal department staff. - Develop and maintain standard operating procedures or local working practices. - Establish regulatory priorities or budgets and...

**Job Title: Regulatory Affairs Associate I (International Regulatory Affairs)** **Career Level - C** **Introduction to Role**: Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and business to...

**General Manager - Quality Assurance and Regulatory Affairs** Educational: - BSc/ M.Sc Science Graduate / Food Microbiologist/Other Relevant Courses. Experience: - 15-20 Years experienced in Food or Herbal or Pharma or Nutraceutical industry. - **Job Description**_ 1) Must have experience in handling audits like International FDA, MHRA, Kosher, Halal,...