IQVIA Regulatory Affairs Vacancies – BSc & MSc Life Sciences Apply
Job Posting: Regulatory Affairs Officer
Location: Thāne, India
Job Type: Full-time
Job ID: R1454074
Job Overview:
Under general supervision, the Regulatory Affairs Officer will prepare and/or review regulatory submission documents to support clinical trials and marketing authorization activities. This role involves providing regulatory support for assigned projects, ensuring compliance with regulations.
Essential Functions:
- Act as a Regulatory Team Member on small, straightforward regulatory projects or single service projects, under senior guidance.
- Identify project needs, track timelines, and implement client requests in collaboration with senior staff.
- Review and prepare regulatory documentation in areas such as Chemistry, Manufacturing, and Controls (CMC), Lifecycle Maintenance, Marketing Authorization Transfers, and Labeling/Publishing.
- Actively participate in project teams with internal and external customers.
- Prepare slides and background material for small business development meetings and present to clients.
- May deliver training as required.
- Perform tasks assigned by Regulatory management and contribute to improving systems and processes.
- Solve minor issues related to processes or systems under senior supervision.
Qualifications:
Education: Bachelor’s or Master’s degree in Lifesciences or a related discipline.
Experience: At least 2 years of relevant experience in regulatory affairs or related fields.
Skills:
- Solid understanding of the Research and Development process (including CMC, Preclinical and Clinical).
- Strong communication and organizational skills.
- Ability to manage multiple projects with direction from senior staff.
- Proficient in Microsoft Office and publishing tools.
- Ability to follow standard operating procedures and recommend improvements.
- Interpersonal skills for effective collaboration with coworkers, managers, and clients.
- Ability to make decisions on discrete tasks with guidance from senior staff.
Additional Requirements:
- Advanced knowledge within a specific discipline, typically gained through extensive experience or education.
- Ability to adjust or enhance systems and processes for improved effectiveness.
- Applicable certifications and licenses as required by country or regulatory bodies.
How to Apply:
Interested candidates can apply by submitting their resumes to the provided contact information on the IQVIA careers page or job listing.
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