Regulatory Affairs Consultant
Parexcel
Bucharest
2 zile în urmă

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.

Success Profile

What makes a successful Consultant at PAREXEL? Check out the top traits we're looking for and see if you have the right mix.

Responsibilities

Regulatory Affairs Consultant (full time, permanent contract) A Consultant must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services PAREXEL Consulting provides.

A consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and / or market.

A consultant ensures the timely performance of work within a project scope to the quality expectations of PC and the client.

When serving as a Project Technical Lead, a Consultant assures the work of the entire team is delivered on time and that it meets client’s and PC’s quality expectations.

We are currently looking for an experienced Consultant who will be responsible for conducting gap analysis of CMC dossiers -

registered details versus manufacturing site master file. They will also support the team with regards to remediation plan.

We are currently looking for an experienced Consultant who will be responsible for conducting gap analysis of CMC dossiers -

registered details versus manufacturing site master file. They will also support the team with regards to remediation plan.

Key requirements :

  • Good understanding of performing the above regulatory tasks on a global level
  • Minimum of 5 years Regulatory Experience
  • Relevant CMC expertise
  • Good project Management skills
  • Proactive approach and excellent communication skills
  • Fluent English and Romanian
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