Regulatory Affairs Associate - Talent Pool
Denmark, Remote Job ID R0000034323 Category Consulting Date Posted 07/03/2025Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
As a Regulatory Affairs Associate you will be responsible for specified product portfolio. This product responsibility includes both
national and central licenses and also projects still in development. You will act as a Subject Matter Expert and/or Key User for one or several expert areas within regulatory department.
Be the regulatory expert providing regulatory expertise on the assigned product portfolio in cross-functional settings to support the business.
Job Responsibilities:
· Prepare and submit relevant regulatory submissions of high quality and in compliance with local regulatory requirements, in a timely manner.
· Ensure effective interaction with authorities to support local/central functions for assigned activities. Respond to questions from the authority in collaboration with the Headquarter.
· Ensure local labelling (SmPC, PIL, pack-label and compendium) are updated and consistent and comply with local regulatory requirements.
· Ensure pack artwork is updated according to local legislation and internal processes.
· Ensure local translations of high quality that are agreed with internal partners, according to SOP, and delivered according to timelines.
· Initiate update of the regulatory databases in a timely/regular manner to ensure compliance.
· Keep fully aware of local and EU regulatory requirements and Internal Regulatory Processes and Policies
· Build/maintain local/central and external relationships to support assigned product portfolio and expert area.
· Provide regulatory input (also including environmental aspects) to the tender process (where applicable) for assigned portfolio.
· Participate in central project groups, when relevant, to ensure an optimal regulatory strategy is implemented.
· Work with supply and business to mitigate consequences of stock-out situations.
· Represent regulatory function in cross-functional teams
· Participate in SOP maintenance and management monitoring activities as necessary.
Knowledge, competence and skills
· University degree in a scientific area
· Initial years of Regulatory Affairs experience
· Good attention to details
· Able to take responsibility and provide leadership
· Collaborative approach and enjoy working in a team
· Able to influence and to liaise with internal and external stakeholders
· Understands both business content and issues in the external environment
· Fluent in English and local language
#LI-REMOTE
Employee Insights
Why Consultants work at Parexel
