Regulatory Affairs Associate

DURHAM, NCPosted 20 days ago

Job summary

• Job post source

  This job is directly from GSK

• Job overview

  The Regulatory Affairs Associate at GSK supports US labeling and regulatory teams to ensure accurate and timely updates of US product information and labeling documents, impacting regulatory compliance and product submissions.

• Responsibilities and impact

  The role involves authoring and managing FDA-compliant labeling documents, coordinating with internal teams to resolve labeling issues, ensuring version control, meeting submission deadlines, and providing regulatory advice on prescribing information requirements.

• Experience and skills

  Requires a Bachelor's degree and at least 1 year of pharmaceutical labeling and regulatory experience; preferred qualifications include a science degree, knowledge of FDA labeling regulations, proficiency with software and medical terminology, and ability to negotiate labeling solutions.

• Work environment and culture

  GSK promotes an inclusive, supportive culture focused on science, technology, talent development, and employee wellbeing, encouraging employees to thrive and grow.

• Company information

  GSK is a global biopharma company focused on vaccines, specialty and general medicines, with core therapeutic areas including infectious diseases, HIV, respiratory/immunology, and oncology, committed to advancing health and sustainable growth.

• Job location and travel

  The position is located at GSK's Durham Blackwell Street site, requiring a minimum of two days onsite per week.

• Application process

  Applicants are encouraged to contact the GSK Service Centre for accommodations; employment agencies must obtain prior written authorization before referrals; US licensed healthcare professionals may be subject to expense reporting for compliance.

• Unique job features

  The role uniquely involves producing FDA-compliant XML labeling documents and requires detailed knowledge of FDA and GSK labeling requirements, positioning the associate as an authoritative source within the company.

Company overview

GSK, or GlaxoSmithKline, is a global healthcare company that researches, develops, and manufactures a wide range of pharmaceuticals, vaccines, and consumer healthcare products. They generate revenue through the sale of prescription medicines, vaccines for diseases such as influenza and hepatitis, and over-the-counter products like Sensodyne and Panadol. Founded in 2000 through the merger of Glaxo Wellcome and SmithKline Beecham, GSK has a rich history of innovation and commitment to improving global health.

How to land this job

• Position your resume to highlight your experience with regulatory labeling, especially your familiarity with FDA requirements and XML labeling document production, as these are central to the Regulatory Affairs Associate role at GSK.

• Emphasize your ability to manage multiple projects concurrently with strong attention to detail, problem-solving skills, and your capacity to communicate regulatory requirements effectively across teams.

• Apply through multiple channels including the GSK corporate careers site and LinkedIn to maximize your chances of being noticed for this position.

• Connect with current employees in the Regulatory Affairs or Labeling teams at GSK on LinkedIn; ice breakers could include asking about their experience working on FDA labeling submissions or commenting on recent GSK labeling initiatives.

• Optimize your resume for ATS by incorporating keywords from the job description like 'FDA-compliant XML labeling,' 'regulatory requirements,' 'prescribing information,' and 'version control' to ensure your resume passes initial automated screenings.

• Utilize Jennie Johnson's Power Apply feature to automate applying through various channels, tailor your resume with the right keywords, and identify LinkedIn connections to network with, allowing you to focus your time on preparing for interviews and other job search activities.