Regulatory Affairs Ba

3 weeks ago


Bengaluru, India CGI Group, Inc. Full time

**Position Description**:
Requirement Regulatory Affairs BA

Recruiter Name Nikitha

Njoyn ID J1122-2759

Primary Skills Regulatory Affairs BA

Secondary Skills Pharma Domain

Experience 3-6+yrs

Notice Period 0-30days

Location Bangalore/ Hyderabad

Detailed Job Description Technical Skills:

- Regulatory Affairs - 3+ Years
- Dossier - 3+ Years
- Product Approval Life Cycle - 3+ Years
- Regulatory Process - 3+ Years
- Training - 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))

**Skills**:

- Business Analysis
- Analytical Thinking

**What you can expect from us**:
**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 success.

When you join CGI, you become a trusted advisor, collaborating with colleagues and clients to bring forward actionable insights that deliver meaningful and sustainable outcomes. We call our employees "members" because they are CGI shareholders and owners, and, as owners, we enjoy working and growing together to build a company we are proud of. This has been our Dream since 1976, and it has brought us to where we are today-one of the world's largest independent providers of IT and business consulting services.

At CGI, we recognize the richness that diversity brings. We strive to create a work culture where everyone belongs, and we collaborate with clients in building more inclusive communities. As an equal opportunity employer, we empower all our members to succeed and grow. If you require an accommodation at any point during the recruitment process, please let us know. We will be happy to assist.

Ready to become part of our success story? Join CGI-where your ideas and actions make a difference.


  • Regulatory Affairs Ba

    4 weeks ago


    Bengaluru, Karnataka, India CGI Full time

    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...


  • Bengaluru, India Parexel Full time

    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)...


  • Bengaluru, Karnataka, India Parexel Full time

    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...


  • 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...


  • 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...


  • Bengaluru, India Novo Nordisk AS Full time

    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...


  • Bengaluru, India Novo Nordisk AS Full time

    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...


  • 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...


  • Bengaluru, India Novo Nordisk AS Full time

    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...


  • Bengaluru, India PSI CRO Full time

    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...


  • Bengaluru, India PSI Full time

    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...


  • Bengaluru, India Sensesemi Technologies Pvt. Ltd. Full time

    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...


  • Bengaluru, India Novo Nordisk Full time

       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...


  • 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,...


  • Bengaluru, India Parexel Full time

    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...


  • Bommasandra, Bengaluru, Karnataka, India Arcos Group of Companies Full time

    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...


  • Bengaluru, India IQVIA Full time

    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...


  • Bengaluru, India Novo Nordisk AS Full time

    Department: Regulatory Affairs Rare Endocrine Disorders Job Level: 7 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...


  • Bengaluru, India Novasyte Full time

    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...


  • Bengaluru, India Lilly Full time

    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...