[Hiring] Senior Regulatory Affairs Associate - CTA Senior Specialist @Parexel

Role Description

We are seeking a Senior Regulatory Affairs Associate - CTA Senior Specialist to join our team in a remote capacity. As a Senior Regulatory Affairs Associate - CTA Senior Specialist, you will support critical clinical trial authorization submissions and regulatory compliance activities that advance new treatments for patients worldwide. This position plays a key role in CTA (Clinical Trial Application) strategy development, submission execution, regulatory authority interactions, and ensuring quality and compliance across global submissions. You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to regulatory submissions from planning through closeout.

Key Responsibilities

• Provide operational and regulatory support for CTA submissions and maintenance activities, ensuring compliance with all applicable requirements.
• Prepare and coordinate global CTA and amendment documentation, managing dossier development and ensuring quality and completeness.
• Manage or facilitate submissions to health authorities or via local personnel, serving as the primary point of contact for regulatory interactions.
• Liaise with and oversee CROs for submissions and query management, ensuring timely and accurate responses to regulatory inquiries.
• Implement global CTA strategy and ensure quality and compliance to country-specific requirements across all regulatory submissions.
• Maintain tracking and archiving of regulatory submissions while communicating EU regulatory requirements and updates to cross-functional teams.
• Contribute to process improvements that enhance efficiency and quality in regulatory submission management.

Qualifications

• Proven leadership in EU CTA documentation and submissions with demonstrated success managing complex regulatory processes.
• Strong knowledge of EU drug development, CTR, and CTIS workflows with ability to apply regulatory expertise across multiple jurisdictions.
• Project management and leadership skills with ability to coordinate cross-functional teams and manage vendor relationships.
• Excellent communication and cross-functional collaboration skills with ability to influence and drive results across organizational boundaries.
• Experience working in clinical research, healthcare, or a regulated environment with strong attention to detail and quality mindset.

Requirements

• Bachelor's degree in Life Science or equivalent experience.
• 6+ years in pharmaceutical industry with 5+ years in Regulatory Affairs.
• Strong knowledge of EU drug development, CTR, and CTIS regulatory frameworks.
• Demonstrated experience with CTA submission processes and regulatory compliance.
• Strong communication, organization, and problem-solving skills.

Preferred Qualifications

• Advanced degree in Life Science, Regulatory Affairs, or related field.
• Familiarity with regulatory submission tracking systems and electronic document management tools.
• Knowledge of additional regulatory pathways beyond EU requirements.

Benefits

• Health, Vision & Dental Insurance.
• Tuition Reimbursement.
• Vacation/Holiday/Sick Time.
• Flexible Spending & Health Savings Accounts.
• Work/Life Balance.
• 401(k) with Company match.
• Pet Insurance.