Match score not available

Regulatory Affairs Associate

UNLIMITED HOLIDAYS - EXTRA HOLIDAYS - EXTRA PARENTAL LEAVE - LONG REMOTE PERIOD ALLOWED

Remote:

Full Remote

Contract:

Full time

Work from:

Romania

Offer summary

Qualifications:

Minimum Bachelor’s Degree in Scientific or Technical Discipline., Familiarity with clinical trial submissions to Regulatory Authorities., Client-focused mindset and excellent communication skills., Proficiency in English and local language..

Key responsabilities:

Manage regulatory activities for CTA submission development.
Attend meetings, advocate realistic timelines, lead global team efforts for high-quality submissions.
Compile core package build, author documentation, resolve submission issues.
Understand project strategy, impact assessment, and delivery status.

Parexel Pharmaceuticals XLarge http://www.parexel.com/

10001 Employees

See more Parexel offers

Job description

Your missions

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.

We are looking for a Regulatory Affairs Associate with Clinical Trial Submissions (CTA) experience to join our growing team in Romania. This role can be office based in Bucharest, home based, or we can offer a hybrid role.

As a Regulatory Affairs Associate you will come with a few years of Regulatory Affairs experience gained in the industry. You will bring experience in Clinical Trial Applications (CTA) from various European locations. You will have a chance to work on submissions for Parexel as well as dedicated for clients. In return we will offer you training and knowledge of the organization’s basic consulting models and methodologies as well as basic knowledge of what services we provide. Under the general direction of a Project Lead and/or Technical SME, you will take responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of the business and the client. We will provide you with support of more senior staff to accomplish more complex tasks. You may act in a client-facing role with clear guidance and support from line management.

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.