Regulatory Affairs Officer , IQVIA Biotech

Key Responsibilities

Serve as Regulatory Team Lead on complex global studies including oversight of technical writing and submission publishing.

Draft review and quality-check clinical trial regulatory core study documentation at global and country level .

Engage directly with clients to clarify clinical trial regulatory pathways share lessons learned and address feedback.

Engage with Competent Authorities in countries across multiple regions as part of the clinical trial regulatory strategy for complex global studies

Monitor scope deliverables timelines and budget; proactively mitigate risks and escalate issues as needed.

Provide guidance and feedback to junior colleagues; support training and continuous improvement initiatives.

Contribute to internal SOP reviews and present regulatory processes at full-service bid defenses.

Perform additional tasks assigned by Regulatory management to meet program goals.

Qualifications

Bachelors or Masters degree in Life Sciences or related discipline.

34 years of relevant clinical trial regulatory experience within CRO or biotech/pharma.

Strong understanding of the R&D continuum (CMC preclinical clinical) and applicable laws guidelines and agency expectations for clinical trials.

Demonstrated expertise in at least one clinical trial regulatory domain (e.g. CMC labeling).

Experience with clinical trial regulatory submission platforms and pathways including but not limited to EU CTR Health Canada US FDA IND submissions and/or systems in other regions such as LATAM or APAC. Biotech therapy area exposure welcomed.

Proficiency with Microsoft Office and regulatory publishing tools (e.g. eCTD systems); meticulous document management skills.

Excellent written and verbal communication organization and stakeholder-management abilities.

Proven ability to manage multiple projects; work in a fast-paced environment with competing priorities; and view obstacles as challenges to be handled with ease and grace; follow SOPs consistently and exercise sound judgment on discrete tasks.

Problem-solving mindset with adaptability in fast-changing environments; self-motivated and collaborative.

IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.