About the Company
IQVIA (NYSE: IQV) is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry dedicated to bringing clients an unparalleled understanding of patients and patient outcomes. Formed through the merger of Quintiles and IMS Health, IQVIA offers a broad range of solutions that harness data science and human science to help clients drive healthcare forward. We are committed to fostering a diverse and inclusive workforce and are proud to support international talent through sponsorship.
Job Description
We are seeking a highly motivated and experienced Regulatory Affairs Manager to join our dynamic team in Montpelier, Vermont. This critical role involves managing regulatory strategies, submissions, and compliance activities for pharmaceutical and medical device products across various global markets. The successful candidate will be instrumental in navigating complex regulatory landscapes, ensuring timely approvals, and maintaining adherence to international regulations. This position offers international sponsorship for qualified candidates.
Key Responsibilities
- Develop and implement global regulatory strategies for new and existing pharmaceutical and medical device products.
- Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, BLAs, 510(k)s, PMAs, CE Marks) to health authorities worldwide, including FDA, EMA, and other international bodies.
- Manage and coordinate responses to regulatory agency inquiries and inspections.
- Ensure ongoing compliance with all applicable regulatory requirements and guidelines throughout the product lifecycle.
- Interpret new and existing regulations and provide strategic guidance to cross-functional teams.
- Participate in product development teams, providing regulatory input and risk assessments.
- Lead and mentor junior regulatory affairs professionals, if applicable.
- Maintain up-to-date knowledge of global regulatory intelligence and trends.
Required Skills
- Bachelor's degree in a scientific discipline (e.g., Pharmacy, Biology, Chemistry).
- Minimum of 5 years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, or medical device industry.
- Strong understanding of global regulatory requirements (e.g., FDA, EMA, ICH guidelines).
- Proven experience with regulatory submissions and approvals.
- Excellent written and verbal communication skills.
- Strong project management and organizational abilities.
- Ability to work independently and collaboratively in a fast-paced environment.
- Demonstrated problem-solving skills and attention to detail.
Preferred Qualifications
- Advanced degree (Master's, Ph.D., Pharm.D.) in a related field.
- RAC (Regulatory Affairs Certification).
- Experience with international product registrations and lifecycle management.
- Prior experience leading regulatory projects or teams.
- Proficiency in additional languages.
Perks & Benefits
- Comprehensive health, dental, and vision insurance.
- 401(k) retirement plan with company match.
- Generous paid time off and company holidays.
- Professional development and continuing education opportunities.
- Life and disability insurance.
- Employee assistance program.
- Opportunity for international sponsorship and relocation assistance.
- Dynamic and collaborative work environment.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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