As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
- Full Time
- Level: Mid
- Travel: Yes
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Success Profile
Check out the top traits we're looking for and see if you have the right mix.
- Detail-Oriented
- Proactive
- Problem-Solver
- Results-Driven
- Organized
- Multi-Tasker
Rewards
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Collaboration
Work with industry leaders and subject matter experts.
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Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
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Variety
Opportunities to work on multiple accounts – never boring!
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Management
Strong management with depth of experience working for global health authorities.
Responsibilities
We are looking for Regulatory Affairs Associates with Clinical Trial Submissions (CTA) experience to join our growing team in Istanbul. This role is office based in Turkey (hybrid model is also available).
As a RA Associate you will come with initial 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
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 language
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.
Recognition and Inclusion: At our organization, you won’t be just another face in the crowd. We celebrate your achievements and value your unique perspective.
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