Regulatory Affairs Consultant
1 month ago
Regulatory Affairs Consultant:
Around 7-10 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologicals) 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, authoring and delivery of regulatory maintenance submissions from either a global and/or regional perspective.Responsible for managing (Authoring and Review) of biologics/biosimilar/vaccine investigational product submission such as IND & IMPD for USFDA, EMAAuthoring, review, and submission of BLA/MAA dossiers for US/EU/ROW /India markets.Preparation of regulatory gap analysis and strategy documents (with remediation plans for identified gaps) for submissions like IND, IMPD, DMF, CTA, BMF, BLA, NDA, and MAA applications.Life cycle management (LCM) for approved products. (annual reports, variations, renewals) for Europe (Type IA/IB/II/IAIN)Evaluation of change controls and deviations and defining regulatory strategyPreparation and submission of scientific advice, briefing book, Type 2 meeting packages for USFDA and EMACo-ordination with internal and external stake holders for documentation required for filing. Identify quality and/or timeliness issues with source documents, as early as possible.Develop up-to-date knowledge about regulatory guidelines and applies regulatory requirements and their impact on submissions.Working experience in Regulatory Information Management Systems like Veeva Vault.Strong communications skills and ability to guide and mentor team members.Ability to work independently.-
Regulatory Affairs Consultant
1 month ago
Bengaluru, India Parexel Full timeRegulatory 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)...
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Regulatory Affairs Consultant
2 weeks ago
Bengaluru, Karnataka, India Parexel Full timeRegulatory 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...
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Regulatory Affairs Ba
4 weeks ago
Bengaluru, Karnataka, India CGI Full timeJob 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...
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Regulatory Affairs Ba
4 weeks ago
Bengaluru, Karnataka, India CGI Full timeRegulatory 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...
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Regulatory Affairs Associate
7 days ago
CV Raman Nagar, Bengaluru, Karnataka, India Indian Institute of Science, Bangalore Full time**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...
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Junior Regulatory Affairs Associate
7 days ago
Bengaluru, Karnataka, India Parexel Full time**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...
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Regulatory Affairs Consultant
9 hours ago
Bengaluru, Karnataka, India Parexel Full time8+ 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...
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Regulatory Affairs Consultant
3 weeks ago
Bengaluru, India Parexel Full timeWhen 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...
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Regulatory Professional I
1 week ago
Bengaluru, India Novo Nordisk AS Full timeDepartment: 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...
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Regulatory Specialist
1 week ago
Bengaluru, India Novo Nordisk AS Full timeDepartment: 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...
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Regulatory Professional I
4 weeks ago
Bengaluru, India Novo Nordisk Full time**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...
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Regulatory Professional II
4 weeks ago
Bengaluru, India Novo Nordisk AS Full timeDepartment: 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...
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Regulatory Affairs Manager.
1 week ago
Bengaluru, India PSI Full timeJob 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...
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Regulatory Affairs Manager
1 week ago
Bengaluru, India PSI CRO Full timeJob 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...
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Senior Regulatory Professional
4 weeks ago
Bengaluru, India Novo Nordisk AS Full timeDepartment: 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...
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Clinical Affair Trainee
7 days ago
Bengaluru, India Sensesemi Technologies Pvt. Ltd. Full time1. 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...
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Regulatory Professional I
1 week ago
Bengaluru, India Novo Nordisk Full timeDepartment: 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...
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Regulatory Professional- Ioso Ra Operations Hub
4 weeks ago
Bengaluru, India Novo Nordisk Full time**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,...
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Regulatory Affairs Executive
7 days ago
Bommasandra, Bengaluru, Karnataka, India Arcos Group of Companies Full timeRoles 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...
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Medical Affairs – Medical Writing
4 weeks ago
Bengaluru, India Lilly Full timeWe’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...