Senior Regulatory Affairs Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Accountable for the planning of submissions, overseeing IND-related activities such as Annual Reports, Orphan Drug Reports, DSUR, and other CTA tasks for ongoing studies or study initiations.

• Responsible for the planning, compilation, quality control, and submission of Investigational Drug Applications (INDs), Biologics License Applications (BLAs), and their amendments.

• Prepares regular IND and CTA amendments, including Annual Reports/DSURs, Investigator Packages, and SUSARs.

• Manages vendors/CROs independently, under limited supervision, to plan and track source documents ensuring the timely delivery of high-quality IND, IND amendments, CTA, and EU-CTR submissions.

• Aids in the execution of regulatory strategies for designated projects and programs throughout all development phases (from IND to NDA/BLA approval and commercialization).

• Collaborates with submission authors and reviewers to confirm that source document planning is thorough and that high-quality documents are approved on schedule, ensuring scientific content, organization, clarity, accuracy, format, consistency, and compliance with regulatory guidelines, styles, and processes.

• Acts as a representative of Regulatory Affairs, offering regulatory expertise to cross-functional teams concerning specific projects and topics.

• Independently oversees the submission tracker for multiple products.

• Maintains records of IND and CTA submissions and correspondence with the FDA or other regulatory bodies.

• Develops templates or frameworks for specific submissions in accordance with company standards.

• Creates and compiles impactful presentations for both external and internal audiences as needed.

• Performs additional duties as assigned.

⛳️ Requirements

• A BS degree is required; an advanced degree (PharmD, PhD, Master's) is preferred. A strong scientific or research background, particularly in pharmacy, chemistry, or biology, is preferred, or relevant experience.

• A minimum of 8 years of experience in regulatory affairs or a related role within drug/biologic development.

• Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format is advantageous.

• Knowledge of US and international regulations and procedures in drug/biologic development; familiarity with ICH and regional regulatory requirements.

• Advanced proficiency in Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro.

• Exceptional attention to detail and accuracy.

• A strong level of motivation and proactiveness is necessary to engage with both in-person and remote team members.

• Outstanding interpersonal, verbal, and written communication skills.

• Ability to work independently with minimal supervision or guidance.

• Comfortable in a fast-paced small company setting with limited direction, able to adapt workload based on shifting priorities.

🏝️ Benefits

• Comprehensive health insurance packages.

• Opportunities for professional development and growth.

• A supportive and collaborative work environment.

• Flexible work arrangements.