Senior Regulatory Affairs Associate - Labelling Specialist

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.

We are seeking a skilled and experienced Regulatory Labeling Specialist to join our team. This client-facing role requires expertise in general labeling processes, regulatory procedures, and advanced document editing skills. The ideal candidate will work closely with clients and internal teams to ensure accurate and compliant labeling for pharmaceutical products across various markets.

Key Responsibilities:

• Apply comprehensive knowledge of labeling procedures and timelines, particularly for the Centralized Procedure in the EU.
• Demonstrate a thorough understanding of the structure and authoring requirements for US Prescribing Information (USPI) and Canada Product Monographs.
• Utilize advanced Microsoft Word editing skills, specifically for structured labeling documents.
• Interact directly with clients, addressing their needs and queries related to labeling processes and requirements.
• Ensure all labeling documents comply with regulatory standards and guidelines.
• Collaborate with cross-functional teams to coordinate labeling activities and timelines.
• Stay updated on regulatory changes and industry best practices in labeling.

Qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, or a related field (advanced degree preferred).
• Minimum of 3-5 years of experience in regulatory affairs or labeling within the pharmaceutical industry.
• In-depth knowledge of global regulatory labeling requirements, with a focus on EU, US, and Canadian markets.
• Proficiency in advanced Microsoft Word features, particularly those related to structured labeling.
• Excellent written and verbal communication skills in English.
• Strong attention to detail and ability to manage multiple projects simultaneously.
• Proven experience in client-facing roles within the pharmaceutical or healthcare industry.

Required Skills:

• Expertise in regulatory labeling processes and timelines.
• Proficiency in authoring and editing USPI and Canada Product Monographs. Advanced Microsoft Word skills, particularly in structured labeling techniques. Strong interpersonal and communication skills for effective client interactions. Ability to work independently and as part of a team in a fast-paced environment.

If you are passionate about regulatory affairs, have a keen eye for detail, and enjoy working directly with clients, we encourage you to apply for this exciting opportunity to contribute to our organization's success in the pharmaceutical labeling field.