Senior Regulatory Affairs Associate- Labeling Strategy

Senior Regulatory Affairs Associate- Labeling Strategy

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.

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose – moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart®.

About the Role

We are seeking a Labelling Strategist to join our team in a Remote capacity. As a Senior Associate Regulatory Affairs professional, you will support the development and management of global labeling strategies that advance new treatments for patients. This position plays a key role in regulatory compliance, labeling lifecycle management, and cross-functional coordination across major markets. You'll collaborate with regulatory, quality, and commercial teams, follow industry-standard processes, and contribute to product success from development through post-approval activities.

Responsibilities include developing and maintaining compliant labeling documents, managing regulatory submissions, coordinating artwork approvals, and ensuring alignment with evolving regulatory requirements. With diverse teams and continuous learning opportunities, this role offers pathways to deepen expertise in global regulatory affairs and influence product outcomes across therapeutic areas.

Key Responsibilities

• Develop, maintain, and update global labeling documents including CCDS, USPI, and regional labels for US, EU, Switzerland, Canada, Australia, and other markets in alignment with regulatory requirements and PRAC/CMDh recommendations

• Manage all post-approval labeling activities including artwork updates, safety variations, xEVMPD submissions, and PSURs with strong attention to regulatory compliance

• Conduct Regulatory Impact Assessments for change controls raised for medicinal products in registered markets

• Coordinate artwork approval processes for printed packaging components, ensuring compliance with design and regulatory requirements for new products, new packs, and packaging changes

• Demonstrate proficiency in SPL across all aspects and troubleshooting, and manage the review and approval of labeling in document management systems

• Monitor and manage artwork change requests, oversee operational processes for artwork creation and translation, and maintain Artwork Trackers and related systems

• Research and prepare comparator labeling documents for global alignment and competitive analysis

• Author labeling components of Annual Reports and maintain compliance with regulatory standards

• Liaise with internal and external stakeholders to ensure timely and accurate implementation of labeling changes across regions

 

You'll thrive in this role if you bring:

• Strengths in regulatory compliance, labeling strategy, and cross-functional collaboration

• Extensive experience in pharmaceutical regulatory affairs and labeling management

• The ability to manage complex regulatory submissions and coordinate across global teams

• Strong attention to detail and commitment to accuracy in regulatory documentation

• Proficiency with regulatory information management systems and labeling tools

 

 

Required Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field, or equivalent professional experience

• 7-8 years of experience in pharmaceutical regulatory affairs, with demonstrated expertise in labeling development and post-approval activities

• In-depth knowledge of labeling regulations and guidelines across major markets (US, EU, Switzerland, Canada, Australia)

• Hands-on experience with CCDS-related submissions, safety variations, and artwork management

• Proficiency in SPL and document management systems

• Strong communication, organization, and problem-solving skills with the ability to manage multiple priorities

 

Preferred Qualifications

• Advanced degree (Master's) in Regulatory Affairs or related field

• Experience with regulatory information management systems such as Veeva, TVT, or Docubridge

• Knowledge of advertising and promotion materials regulations

• Experience managing labeling across multiple therapeutic areas

 

If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

Experience Level

Mid Level