[Hiring] Senior Regulatory Affairs Associate @Parexel

Role Description

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.

Qualifications

• 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.

Requirements

• 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.

Benefits

• 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.