Regulatory Affairs Professional

3 weeks ago

United Kingdom Parexel Full time

Parexel is seeking highly motivated and experienced individuals for the position a Senior Regulatory Affairs Associate. This role can be home, or office based in various locations in Europe . As part of our team, you will have the opportunity to work within a collaborative environment and deliver services within your technical expertise. Join us and make a difference in clinical research

Main Role Responsibilities:
  • Demonstrate the ability to prioritize work and define steps needed to achieve project outcomes.
  • Liaise closely with more senior colleagues to discuss issues and resolve conflicts.
  • Provide suggestions for improving project efficiencies and results to the project technical lead.
  • Seek out information from previous projects, other client work, or colleagues to complete assigned project activities.
  • Produce quality work that meets the expectations of the project Team Lead and the client.
  • Serve as a Regulatory Lead for small scale projects or work streams.
  • Ensure accurate project reporting is in place as the main client contact.
  • Ensure project team compliance and adherence to project scope and objectives.
  • Identify new opportunities through Change In Scope or add-on businesses from existing work.
  • Ensure timely project close-out activities are completed.
  • Follow and implement the organization's consulting models and methodologies.
  • Provide technical and/or business consulting services within your personal area of expertise.


Requirements:

  • Previous experience working in industry in support of Global Labeling, Regulatory (Clinical/Safety), or Medical Writing for labeling updates.
  • Understanding of the Regulatory processes required to update labeling of a product.
  • Familiarity with the Company Core Datasheet (CCDS), and its implementation into labeling and artworks.
  • Understanding of Safety Signal Management and the impact of confirmed safety signals on labeling.
  • Understanding of Periodic Safety Update Reports (PSUR) and potential impact on labeling.
  • Knowledge of the relationship between labeling and artwork processes.
  • Familiarity with the Addendum to Clinical Overview (Module 2.5) and its preparation to support a labeling variation.
  • Knowledge of Regulatory requirements for labeling updates in different regions (EU, US, and APAC).
  • Understanding of EU readability and PIL (Patient Information Leaflet) testing.


Skills and Qualifications:

  • University degree in a scientific field
  • Strong organizational and time management skills.
  • Excellent communication and oral skills, with the ability to work efficiently as part of a team.
  • Strong interpersonal skills.
  • Proactive and efficient work ethic.


#LI-REMOTE

#J-18808-Ljbffr

  • Drug Regulatory Affairs Professional

    4 weeks ago

    United Kingdom Igmpiindia Full time

    Conferment of the prestigious "BUREAU OF INDIAN STANDARDS (BIS) AWARD OF HONOUR 2023" to IGMPI Certified Drug Regulatory Affairs Professional IGMPI has brought an opportunity to become a Certified Drug Regulatory Affairs Professional for those who understand the basic stages of the industrial production life cycle and their regulatory requirements. The...

  • Regulatory Specialist

    2 weeks ago

    United Kingdom VRS Regulatory Full time

    Join the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring, classifications,...

  • Regulatory Specialist

    2 weeks ago

    United Kingdom VRS Regulatory Full time

    Join the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring,...

  • Regulatory Specialist

    2 weeks ago

    United Kingdom VRS Regulatory Full time

    Join the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring, classifications,...

  • Regulatory Affairs Specialist

    7 days ago

    United Kingdom Meet Recruitment Limited Full time

    Senior Consultant Specialising In Regulatory Affairs I am seeking a highly motivated and experienced Regulatory Affairs Specialist with expertise within OTC/Cosmetics experience to join us on a contracted basis for a period of 6 to 12 months. As a key member of the Regulatory Affairs team, you will play a crucial role in ensuring our products comply with...

  • Regulatory Affairs Specialist

    2 weeks ago

    United Kingdom Meet Recruitment Limited Full time

    Regulatory Affairs Specialist - Medical Device Job Title: Regulatory Affairs Specialist - Medical Device Location: Fully remote Company Description: We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to...

  • Regulatory Affairs Specialist

    4 days ago

    United Kingdom Meet Recruitment Limited Full time

    Regulatory Affairs Specialist - Medical Device Job Title: Regulatory Affairs Specialist - Medical Device Location: Fully remote Company Description: We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to...

  • Regulatory Affairs Specialist

    4 weeks ago

    United Kingdom Corin Group Full time

    Corinium Centre, Love Lane Industrial Estate, Cirencester GL7 1YJ, UK Req #233 04 April 2024 Corin is seeking a Senior Regulatory Affairs Specialist to be responsible for product registration and all regulatory aspects of post-market surveillance. The Senior Regulatory Affairs Specialist will require extensive knowledge of all applicable standards,...

  • Regulatory Affairs Specialist

    3 days ago

    United Kingdom Meet Recruitment Limited Full time

    Regulatory Affairs Specialist - Medical Device 2 weeks ago Be among the first 25 applicants Job Title: Regulatory Affairs Specialist - Medical Device Location: Fully remote Company Description: We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance...

  • Director / Associate Director Regulatory Affairs

    2 weeks ago

    United Kingdom Meet Full time

    Associate Director (Regulatory Affairs)My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join our team as Associate Director of Regulatory...

  • Director / Associate Director Regulatory Affairs

    2 weeks ago

    United Kingdom Meet Full time

    Associate Director (Regulatory Affairs) My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join our team as Associate Director of Regulatory Affairs....

  • Director / Associate Director Regulatory Affairs

    2 weeks ago

    United Kingdom Meet Full time

    Associate Director (Regulatory Affairs)My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join our team as Associate Director of Regulatory...

  • Director / Associate Director Regulatory Affairs

    2 weeks ago

    United Kingdom Meet Full time

    Associate Director (Regulatory Affairs) My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join our team as Associate Director of Regulatory Affairs....

  • Director / Associate Director Regulatory Affairs

    2 weeks ago

    United Kingdom Meet Full time

    Associate Director (Regulatory Affairs) My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join our team as Associate Director of Regulatory Affairs....

  • Senior Regulatory Affairs Associate

    3 weeks ago

    United Kingdom Meet Recruitment Limited Full time

    Job Title: Senior Regulatory Affairs Associate Location: Fully remote Company Description: We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team. Position Overview: As a...

  • Regulatory Affairs Interim

    3 weeks ago

    United Kingdom CSR Group Full time

    Job Title: Regulatory Affairs Consultant (Cosmetics) Company Overview: A leading company we represent is pharmaceutical company specializing in cosmetics, committed to delivering high-quality and innovative products that enhance the beauty and well-being of our customers. We are seeking a talented Regulatory Affairs Consultant with expertise in cosmetics...

  • Freelance Regulatory Affairs Consultant

    2 weeks ago

    United Kingdom RBW Consulting Full time

    UK Based Freelance EU IVD Regulatory Affairs Consultant RBW Consulting are working in partnership with a global mid-sized CRO in their search for a Freelance IVD Regulatory Affairs Consultant based in the EU to start as soon as possible within their IVD function. Local ethics committee submissions and Annex XIV submissions for clinical trial assay across...

  • Senior Regulatory Affairs Associate contract job

    3 weeks ago

    United Kingdom Meet Recruitment Limited Full time

    Job Title: Senior Regulatory Affairs Associate Fully remote We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team. As a Senior Regulatory Affairs Associate, you will play...

  • Ad-Hoc Senior Regulatory Affairs Consultant

    4 weeks ago

    United Kingdom Brightwork Ltd Full time

    BaxMed – Ad-Hoc Senior Regulatory Affairs Consultant Led by Stuart Baxter, a seasoned professional with a distinguished career in Regulatory Affairs, BaxMed Regulatory Ltd is an exciting early-stage organisation formed to provide Regulatory and Quality Compliance Services for the global Medical Device / healthcare sector. With a core ethos and commitment...

  • Director / Associate Director Regulatory Affairs

    2 weeks ago

    United Kingdom Meet Recruitment Limited Full time

    Director / Associate Director Regulatory Affairs 2 days ago Be among the first 25 applicants My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join...