Are you experienced in leading the strategy behind how life-changing therapies are communicated to the world, ensuring innovative products are supported by clear, compliant, and high-quality documentation that enables safe and effective use across global markets?
Join Our Growing Team of Regulatory Professionals!
Parexel is seeking an experienced and highly motivated Associate/Senior Associate for Labeling Operations. This role is responsible for extensive coordination and communication across countries and sites, working closely with CMC and Supply Chain owners. The role includes managing artwork mock‑ups and supporting government tenders. Strong labeling and artwork experience, solid project management skills, and familiarity with seasonal vaccine activities are important. US knowledge is also required.
You will join a team of regulatory experts as a part of a large, dedicated client FSP program.
As a Regulatory Affairs Senior Associate/Labeling you will:
- Play a crucial part in coordinating various Global regulatory submissions ie. INDs, IMPDs, BLA/NDS/MAA post-approval commitments, Annual Reports, and Responses to regulatory authority questions.
- Assist in the preparation and coordination of global regulatory submissions, ensuring all submissions are complete, accurate, and compliant with regulatory requirements
- Manage submission timelines and coordinate with cross-functional teams to gather necessary documentation
- Support the team in conducting regulatory assessments of manufacturing changes, analyze the potential impact, and assist in preparing documentation to support manufacturing change assessments
- Facilitate effective communication between cross functional teams and regulatory authorities
- Participate and facilitate project team meetings to provide regulatory input and updates
- Maintain accurate and up-to-date regulatory documentation
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