Senior Regulatory Affairs Associate

(Senior) Regulatory Affairs Associate - Clinical Trials Application page is loaded

(Senior) Regulatory Affairs Associate - Clinical Trials Application

Apply locations Turkey-Istanbul time type Full time posted on Posted 30+ Days Ago job requisition id R0000016376

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.

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

We are looking for a ( Senior) Reg ulatory Affairs Associate with Clinical Trials Submissions experience to join our growing team in Istanbul.

Key Accountabilities:
- Typically works within a team environment but may work; independently delivering services within their technical area of expertise; 
- Works within broad project guidelines but liaises closely with more; senior colleagues to discuss issues and resolve conflicts
- Demonstrates ability to prioritize work and define steps needed to; achieve specified project outcomes
- Follows and implements the organization’s consulting models and methodologies
- Provides technical and/or business consulting services within 
personal area of expertise
- Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability 
- Collaborates with colleagues and client to identify and resolve technical and process issues
- Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience
- Communicates potential new business leads to PC management and account managers
- May participate in project scoping calls and/or proposal preparation with the support of senior colleagues
- Meets established metrics as specified in scorecard on an annual basis 
- Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management.

Skills and Experience required for the role:

- University degree
- Previous clinical trial regulatory submission experience
- Previous CRO / Pharma, Regulatory agency experience
- Excellent interpersonal and intercultural communication skills, both written and verbal
- Client-focused approach to work
- Fluency in English

We encourage you to apply now and begin your career with Parexel!

Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world.

We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.