Regulatory Affairs Associate - Labeling / Marketing Application

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.Regulatory Affairs Associate is responsible for managing labeling ensuring that biological product labels, artwork, translation and packaging components comply with the regulatory requirements of each Local country. The role supports marketing authorization submissions, lifecycle management, and post approval variations requiring labeling updates.A. Labeling & Artwork ManagementPrepare, review, and update product labeling according to requirements from Health authoritiesEnsure localized labeling content (language, warnings, dosage, contraindications) complies with each country’s standards.Coordinate artwork development and version control with internal teams and external vendors.B. Regulatory SubmissionsSupport Marketing Authorization Applications (MAAs), renewals, and variations that involve labeling changes.Prepare labeling sections of the dossier per local format (CTD/eCTD with country‑specific annexes)C. Cross‑Functional CollaborationWork closely with RA, QA, supply chain, artwork teams, and local affiliates to ensure labeling accuracy and timely updates.Act as liaison between global teams and local representatives.Business DevelopmentBegin networking within the industry (i.e. maintain contacts and relationships with clients once engagements are complete)Communicates potential new business lead to PC management and account managersParexel-related ActivitiesMeets established metrics as specified in scorecard on an annual basisCompletes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, training compliance, project deliverable archiving, participation in internal initiatives/projectsDefines self-development activities with the support of management in order to keep current within the industrySkills:Client-focused approach to workResults orientationTeamwork and collaboration skillsConsulting skillsExcellent interpersonal and intercultural communication skills, both written and verbalCritical thinking and problem-solving skillsProficiency in local language and extensive working knowledge of the English languageKnowledge and Experience:Initial years of experience in an industry-related environmentEducation:Minimum of a Bachelor’s Degree in a Scientific or Technical DisciplineOriginally posted on Himalayas