Senior Regulatory Affairs Associate - CTA Senior Specialist

Regulatory Toolkit; United States; Teletrabalho; USD 120 000 - 180 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Resumo da oferta

Parexel, a global clinical development partner, is expanding its team and seeks a Senior Regulatory Affairs Associate - CTA Senior Specialist to join remotely. You will support critical CTA submissions, regulatory compliance, and strategy across global submissions while collaborating with cross-functional teams.

The role emphasizes EU CTR/CTIS workflows, regulatory authority interactions, and continuous learning to influence the path for innovative therapies; strong leadership and communication

Qualificações

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

Responsabilidades

• Provide operational and regulatory support for CTA submissions and maintenance activities.
• Prepare and coordinate global CTA and amendment documentation.
• Manage or facilitate submissions to health authorities; primary regulatory contact.
• Oversee CROs for submissions and query management; ensure timely responses.
• Implement global CTA strategy and ensure country-specific compliance.
• Maintain tracking and archiving of submissions; communicate EU regulatory changes.
• Contribute to process improvements in submission management.

Conhecimentos

Proven leadership

EU CTA documentation

Project management

Excellent communication

Regulatory environment experience

Formação académica

Bachelor's degree in Life Science or equivalent experience

Advanced degree in Life Science or regulatory field

Ferramentas

Regulatory submission tracking systems

Electronic document management tools

Descrição da oferta de emprego

When our values align, there's no limit to what we can achieve.At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart(R).

About the Role

We are seeking a Senior Regulatory Affairs Associate - CTA Senior Specialist to join our team in a remotecapacity. 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.

Responsibilities include preparing and coordinating global CTA documentation, managing submissions to health authorities, implementing regulatory strategy, and maintaining compliance with evolving regulatory requirements. With diverse teams and continuous learning opportunities, this role offers the chance to deepen your expertise in regulatory affairs and influence the path forward for innovative therapies.

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

Candidate Profile

You’ll thrive in this role if you bring:

• 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

Required Qualifications

• 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 and Compensation

• 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

For a complete list of benefits, please visit www.parexel.com/us-benefits.

Parexel offers competitive salaries based on several factors, including the position and level offered, skills, education, training, experience, professional achievements, and location.

Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.

We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.