Regulatory Submission Specialist Jobs

Robert Half's client is seeking a Client-Facing Regulatory Submissions Specialist/Account Coordinator for a REMOTE , ongoing contract opportunity. This position will be 30-40 hours per week.

***VEEVA is required***

: Regulatory Submissions Specialist with Veeva

We are seeking a highly skilled and motivated Pharma Regulatory Submissions Specialist with expertise in using Veeva software to join our team. As a key member of our regulatory affairs department, you will play a critical role in the preparation, submission, and management of regulatory documents for pharmaceutical products.

Responsibilities:

1. Regulatory Submissions Management: Collaborate with cross-functional teams to compile, review, and submit regulatory documents for new drug applications (NDAs), investigational new drug applications (INDs), and other submissions to health authorities.
2. Veeva Expertise: Utilize your in-depth knowledge of Veeva software to manage, track, and organize regulatory submissions efficiently. Provide guidance to team members on best practices for using Veeva in regulatory operations.
3. Compliance and Quality Assurance: Ensure regulatory submissions comply with all relevant regulations, guidelines, and internal policies. Perform quality checks to maintain the accuracy and completeness of submission content.
4. Lifecycle Management: Facilitate updates and amendments to existing regulatory submissions throughout the product lifecycle, including post-approval changes, periodic reports, and safety updates.
5. Document Management: Maintain the electronic document management system, ensuring proper version control and accessibility of regulatory documents.
6. Health Authority Interactions: Assist in preparing for and supporting meetings with health authorities, including compiling briefing documents and responding to regulatory inquiries.
7. Regulatory Intelligence: Monitor and stay current with relevant regulatory guidelines, requirements, and industry trends to inform regulatory strategies and submissions.
8. Cross-Functional Collaboration: Collaborate with regulatory affairs, clinical, quality, and other relevant teams to gather necessary information for submissions and address any regulatory concerns.
9. Continuous Improvement: Identify opportunities for process optimization and contribute to the development and implementation of best practices for regulatory submissions.

Requirements:

1. Bachelor's degree in a related field, such as life sciences, pharmacy, or regulatory affairs.
2. experience in regulatory affairs within the pharmaceutical industry, with a focus on regulatory submissions management.
3. Proficiency in using Veeva software, including experience with Veeva Vault
4. Strong understanding of global regulatory requirements and guidelines (e.g., FDA, EMA, ICH).
5. Excellent attention to detail, organizational skills, and the ability to prioritize tasks effectively.
6. Solid understanding of document management systems and electronic submission standards (eCTD).
7. Strong analytical and problem-solving skills with a proactive approach to issue resolution.
8. Effective communication and interpersonal skills, with the ability to work collaboratively in a team-oriented environment.
9. Familiarity with pharmaceutical development processes and drug approval pathways.

Join our dynamic team and make a significant impact on the successful regulatory submissions and approvals of our pharmaceutical products. Apply your expertise in Veeva and regulatory affairs to contribute to the advancement of groundbreaking therapies that improve patients' lives.