Regulatory Affairs Consultant

Regulatory Affairs Consultant.8 years' experience in handling life cycle management of approved drug products (small molecules) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresLead and / or contribute to the planning, preparation (including authoring where relevant) and...

Job Title: Regulatory Affairs BA Position: Software Engineer Experience: 3- 7 Years Category: Software Development/ Engineering Main location: India, Karnataka, Bangalore Employment Type: Full Time **Insights you can act on** While technology is at the heart of our clients’ digital transformation, we understand that people are at the heart of business...

Regulatory Affairs Business Analyst Technical Skills: - Regulatory Affairs - 3+ Years - Regulatory Publishing, CMC, eCTD - 3+ Years - Regulatory Process - 3+ Years Technical Skill Capability Level: - Communication - 4 (Capability Level (Scale of 1 -5)) - Working with US Teams - 4 (Capability Level (Scale of 1 -5)) **Insights you can act on** While...

**About Company**: Foundation of Science, Innovation and Development (FSID) and Department of Design and Manufacturing (DM) at Indian Institute of Science (IISc), Bengaluru support the research, development, and commercialization of affordable and accessible medical devices for indigenous and resource constrained populations. The research team from IISc is...

**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...

8+ years' experience in handling life cycle management of approved drug products (like- tablets (oral solids), syrups (oral liquids), parenterals (injections/ injectables for EU market.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresLead and / or contribute to the planning, preparation...

When our values align, there's no limit to what we can achieve.   Job Description: Relevant experience in regulatory package preparation, compilation and submission to Health Authorities in various markets  with focus on EU countries . Working knowledge of EU regulatory procedures including adaptability to strict Health Authority and Sponsor...

Department: RA Submission Systems Development Are you passionate about ensuring compliance and streamlining regulatory processes in the dynamic field of life sciences? Do you have a passion for regulatory affairs and a desire to shape the future of the industry? We are looking for a Regulatory Process Expert to join the team implementing...

Department: Regulatory Affairs Rare Endocrine Disorders Are you passionate about ensuring regulatory compliance for early phase products and/or managing product life cycle and amendments? Do you want to play a crucial role in keeping patients safe and ensuring Novo Nordisk’s license to operate by supporting in creating regulatory strategies? We...

**Department**:RA CMC Biotech and Rare Disease **About the department** Regulatory Affairs plays an important role in ensuring all Novo Nordisk Medicines and Devices developed with compliance and keeping patients in mind. Liaising between relevant authorities and Novo Nordisk stakeholders, Regulatory Affairs will be involved throughout phases of product...

Department: Labelling Operations Are you skilled in graphic design and have experience in regulatory affairs? Are you ready for the next step in your career? We are looking for a Regulatory Professional II to join our Global Regulatory Affairs team in Novo Nordisk. If you have a passion for design and ensuring regulatory compliance, read on and apply...

Job Description You will focus on leading regulatory services for global research projects of novel medicinal products in India while joining our global team of regulatory and ethics submissions experts. Join our team and contribute to groundbreaking clinical research.  Office-based in Bangalore Oversee preparation of clinical trial submission...

Job DescriptionYou will focus on leading regulatory services for global research projects of novel medicinal products in India while joining our global team of regulatory and ethics submissions experts. Join our team and contribute to groundbreaking clinical research. Office-based in BangaloreOversee preparation of clinical trial submission dossiers for...

Department: Regulatory Affairs Rare Blood Disorders Are you passionate about driving regulatory strategy and life cycle management of product portfolio ensuring interactions with regulatory authorities across the globe? Do you thrive in a multi-disciplinary environment requiring a unique combination of scientific insights and ability to navigate tight...

1. Assisting Regulatory Stack preparation. 2. Assisting Medical affair contents management and creation. 3. Assisting teams across departments, in their regulatory compliance adherence. 4. Ability to research articles to relate regulatory and clinical needs to relevant technology(s). **Job Types**: Fresher, Internship Contract length: 6...

   Department: RA Submission Systems Development Are you passionate about ensuring compliance and streamlining regulatory processes in the dynamic field of life sciences? Do you have a passion for regulatory affairs and a desire to shape the future of the industry? We are looking for a Regulatory Process Expert to join the team implementing centralised...

**Department: International Operations Regulatory Affairs** **About the department** International Operations Regulatory Affairs Bangalore in Global Regulatory Affairs Global Business Services (GBS) is a global RA hub consisting of high calibre regulatory professionals. The objective of the team is to offer core RA competencies enabling NN secure fast,...

Roles and Responsibilities: - Asking for necessary technical inputs from various departments in the Factories and doing its assessment. - To give the necessary technical inputs required by the respective government departments (FDA, CDSCO ) under the guidance of the Head Regulatory - Compilation, review and submission of DMF (Drug master file) to Regulatory...

We’re looking for people who are determined to make life better for people around the world. Purpose:   Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across...

Job Description - Data Management: Ensuring accurate and up-to-date product information is entered into the xEVMPD database, including details such as product name, active substances, dosage forms, indications, and packaging information. - Database Administration: Overseeing the management and administration of the xEVMPD database, including user access...