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Senior Regulatory Affairs Associate- Labeling

extra holidays - extra parental leave - fully flexible
Remote: 
Full Remote
Experience: 
Mid-level (2-5 years)
Work from: 
India

Offer summary

Qualifications:

4+ years in drug development, Knowledge of labeling regulations, Experience in label development, Proficiency in electronic document management systems.

Key responsabilities:

  • Create and manage comparator labeling documents
  • Coordinate artwork approval processes
Parexel logo
Parexel XLarge http://www.parexel.com
10001 Employees
About Parexel
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
See more Parexel offers

Job description

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.

Job Description-

  • Must have  4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
  • Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging)
  • The ability to research and create comparator labeling documents.
  • Strong understanding and experience creating annual reports.
  • The ability to collaborate with Tech Ops for artwork implementation.
  • Proficiency in SPL (all aspects, types, and troubleshooting) and the ability to manage the review and approval of labeling in a document management system.
  • Electronic document management systems use and / or electronic submission experience.
  • Life Cycle Management, Post Approval Labeling submissions including PSUR submissions.
  • Must have handled CCDS related submission / safety variations / PSUR / xEVMPD / Label and artwork updates.
  • Co-ordinate artwork approval process of printed packaging components to meet packaging design and legislation requirements for each new product, new packs or changes to existing packaging.
  • Monitor, manage and control artwork changes.
  • To manage and maintain the Artwork Trackers & Systems.
  • To ensure artwork PDF’s are maintained and latest versions are readily available.
  • Liaise with relevant internal and external suppliers/departments to assist with implementation being achieved

           

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Regulatory AffairsDocument ManagementElectronic SubmissionMedical EquipmentLifecycle ManagementDrug DevelopmentPackaging Regulations

Other Skills

  • Packaging And Labeling
  • Collaboration
  • Research
  • Problem Solving
Are you interested?

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