Senior Regulatory Affairs Associate (CTA)

Main responsibilities:

• Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development and completion of relative associated documentation as required.

• Lead and attends relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities.

• Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.

• Manages the compilation for core package build, contributing to CTA and authoring documentation as required.

• Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.

Knowledge and experience required for the role:

• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline

• A few years of experience in a CRO/Pharma

• Experience in clinical trial submissions to the competent Regulatory Authorities

• Client-focused approach to work

• Excellent interpersonal and intercultural communication skills, both written and verbal

• Critical thinking and problem-solving skills

• Proficiency in English and local language (written and spoken)

• University degree

Parexel is offering a comprehensive benefits package to ensure your success and growth in this role. We provide training and knowledge of our organization's basic consulting models, methodologies, as well as an understanding of the services we offer. Moreover, you will receive support from our senior staff to accomplish more complex tasks successfully.