Senior Regulatory Affairs Associate / Consultant - Labeling Operations (Long term temp)

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.

Fantastic opportunity to bring your labeling operations experience to Parexel as a temporary employee supporting a large client partnership with their labeling strategy and ensuring that labeling documents are of high quality and compliant for the safe and effective use of their products for patients and healthcare providers globally.

As a Global Labeling Senior Regulatory Affairs Associate / Consultant, you will be responsible for:

• Artwork coordination between Regulatory/Labeling and Artwork/Change Management teams

• Structured Product Labeling (SPL) management

• Supporting the development and maintenance of core, EU and US labeling documents

• Tracking core labeling implementation at a regional/country level

What You’ll Do

Labeling Operations:

• Act as intermediary between Regulatory/Labeling and Artwork/Change Management Teams to ensure changes to the planned artwork activity and implementation timelines are communicated

• Record regulatory assessments and ensure Change Management System is appropriately linked to the Regulatory Tracking System

• Support the Regulatory/Labeling team to provide the SPL version of the USPI to the FDA via a vendor

Create and update labeling documents:

• Support the development/ maintenance of regulatory compliant, competitive and high-quality labeling documents throughout the product lifecycle including the Company Core Data Sheet (CDS), Global Patient Leaflet, Target Label Profile, EU Product Information (EUPI) and US Prescribing Information (USPI)

• Support the cross functional product labeling team on labeling matters, accurately capture and communicate decisions, and obtain endorsement by senior management

• Distribute and track CDS updates, maintaining compliance within the Electronic Document Management System and the regulatory tracking system

• Support the delivery of EUPI and USPI according to company strategy, Health Authority regulations and timelines

Oversee regional/country implementation:

• Track implementation of CDS updates, maintaining compliance within the EDMS and the Regulatory Tracking System

• Support Regional and Local Regulatory Leads in responding to Health Authority queries related to labeling and collaborate with Regulatory Leads to identify and track Country Labeling Differences

Maintain labeling compliance:

• Maintain labeling compliance, ensuring version control and tracking of labeling documents in relevant company systems

• Create, maintain and update regulatory labeling procedures and SOPs and support relevant audits and inspections

• Maintain knowledge of current rules and regulations governing global labeling activities

• Provide training to internal stakeholders and new joiners on labeling process requirements

Who You Are

• You will have a passion for regulatory labeling and an excellent eye for detail.

• You will also have a demonstrated understanding of the importance of labeling governance and compliance.

• You will have an interest in working closely with this team for at least the next 6-12 months with the possibility of extension

Required Skills

• 3+ years pharmaceutical/biotechnology industry experience (at least 2 years in regulatory labeling)

• Knowledge and understanding of applicable regulations, pharmacology, medicine, pharmacovigilance and drug development

• Proven experience with document management, regulatory tracking and change management systems

Preferred Skills

• Bachelor's degree in a scientific or medically related discipline preferred

Due to the location of the client, candidates located in the EST are strongly preferred

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EEO Disclaimer
Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.