Senior Regulatory Affairs Consultant

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

📋 Description

• Collaborate with study teams to oversee essential regulatory activities, standards, and deliverables related to the development of CTA submissions.

• Facilitate and participate in pertinent meetings to advocate for realistic timelines, comprehend project strategies, evaluate impacts, and communicate the status of global submission deliveries.

• Assist and lead global team initiatives to guarantee high-quality, compliant components for submissions.

• Oversee the assembly of the core package and contribute to the authoring of CTAs and related documentation.

• Identify, report, and resolve issues impacting submission builds or the logistics of global submission deliveries in collaboration with regional and local partners or Health Authorities.

• Ensure that client assignments are completed and delivered punctually, meeting both business and client quality standards.

• Operate in a client-facing capacity with guidance and support from management.

⛳️ Requirements

• A minimum of a Bachelor’s Degree in a Scientific or Technical Discipline.

• Significant experience within a CRO or Pharmaceutical environment.

• Familiarity with clinical trial submissions to relevant Regulatory Authorities.

• A client-centric approach to work.

• Exceptional written and verbal communication skills, both interpersonally and interculturally.

• Strong critical thinking and problem-solving abilities.

• Proficient in English and the local language, both written and spoken.

• A university degree.

🏝️ Benefits

• Training and insights into Parexel's foundational consulting models and methodologies.

• Awareness of the services offered by Parexel.

• Guidance from senior staff on more complex assignments.

• An annual performance-based bonus plan for eligible positions.

• An annual salary review for eligible positions.

• Total rewards incentives for eligible positions.

• A comprehensive benefits package.