Match score not available

Senior Regulatory Affairs Associate,Biologics

extra holidays - extra parental leave - fully flexible
Remote: 
Full Remote
Contract: 
Work from: 

Offer summary

Qualifications:

4 to 8 years of experience in regulatory affairs, specifically with biologics., Proficient in authoring and compiling country-specific submission files for regulated and emerging markets., Strong understanding of regulatory guidelines and frameworks, particularly for biologic products., Experience with Regulatory Information Management Systems, such as Veeva Vault..

Key responsabilities:

  • Author and compile submission files for marketing authorization applications and post-approval changes.
  • Prepare and deliver regulatory maintenance submissions, adapting to increasing complexity.
  • Execute and maintain submission delivery and content plans, providing updates to stakeholders.
  • Collaborate effectively with team members and work independently to meet regulatory requirements.

Parexel logo
Parexel XLarge http://www.parexel.com
10001 Employees
See all jobs

Job description

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.

Senior Regulatory Affairs Associate ( Biologics )

  • 4 to 8 years of experience of authoring, compiling and submission of country-specific submission files (MAA,  and post-approval changes) of Biologic products in various markets - Regulated (EU/US/Canada) and Emerging Markets. Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
  • Good understanding of regulatory guidelines, regulatory framework, including regional trends, for various types of applications and procedures. Working experience in Regulatory Information Management Systems like Veeva Vault.
  • Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
  • Strong communications and collaboration skills. Ability to work independently. 

Required profile

Experience

Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Collaboration
  • Communication

Regulatory Affairs Manager Related jobs