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Regulatory Affairs Senior Associate

Bucharest, București, Romania Date posted 05/14/2019 Job ID 52548BR

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
  • Glassdoor Rating 3.5

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
  • "They say if you are passionate about what you do, you will never work a day in your life. I can honestly say that this applies to me. I love what I do."

    Jasen - Consultant
  • "My experience so far with Parexel has been great! I had initially started at Parexel as an Independent Consultant but was then presented with a full time job opportunity to really become a part of this fascinating company. I have enjoyed the flexibility to be able to orchestrate a good work/life balance, as well as learn from so many experts in consulting arena and really have a hands-on role with every day bringing a new but exciting challenge."

    Aqip – Consultant
  • "I was offered an incredible opportunity to continue my career in regulatory affairs without relocating 1,000 miles away and making major life changes. Parexel is an innovative, growing company which offers much needed flexibility and opportunities for professional growth."

    Blaine – Consultant
  • "Parexel is a very large organization and holds a top position amongst the different companies engaged in the Consulting business. It can offer many opportunities for development and career progression. Also the diversity of projects can offer a great expansion of knowledge in many areas of the Regulatory Affairs arena. Last (but not least), Parexel offers a variety of rewards to the employees (bonus scheme, benefits etc)."

    Giannis – Consultant
  • "Parexel is a CRO that I had always inspired to join because of the variety of knowledge, experts, culture, flexibility and exposure to be client facing as well as to use my technical knowledge all under a professional and diligent environment. I believe it has provided me the right platform to grow both professionally and individually with the opportunities to present my views and to dialogue with colleagues and clients with all but positive outcomes."

    Aqip – Consultant

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.

Responsibilities

Project Execution
  • Works effectively within a team environment
  • Works within broad project guidelines as directed by the project Technical Lead With the guidance of the project Technical Lead, demonstrates the ability to prioritize work to achieve specified project outcomes
  • Capitalizes on opportunities to improve ones own performance and seeks feedback from the project Team Lead and colleagues
  • Applies information provide by the project Team Lead or senior colleagues to complete assigned project activities
  • Produces quality work that meets the expectations of project Team Lead and the clientConsulting Activities and Relationship Management
  • Follows the organization’s consulting models and methodologies under the guidance of the Project Lead
  • Delivers a limited range of consulting services within personal area of expertise under the guidance of the Project Lead
  • Completes assigned activities within project scope and objectives under the direction of the Project Lead
  • Identifies project and internal issues to senior colleagues and Project Lead
  • Interacts professionally at all working levels within a client
  • organization and within PAREXEL
  • Identifies project and/or client needs to the Project Lead
Business Development
  • Begin networking within the industry (i.e. maintain contacts and relationships with clients once engagements are complete)
  • Communicates potential new business lead to PC management and account managers
Parexel related Activities
  • 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
  • Defines self-development activities with the support of management in order to keep current within the industry

Qualifications

  • Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline
  • 1-3 years of experience in Regulatory Affairs wihin Pharma or a Consultancy
  • Fluent English
  • Outstanding communication skills

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