Regulatory Affairs

3 weeks ago

United Kingdom Parexel Full time

Regulatory Affairs Professional - Labelling (EU/UK)
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 Create a job alert and receive personalised job recommendations straight to your inbox.
#J-18808-Ljbffr

  • Senior Regulatory Affairs Specialist

    11 hours ago

    United Kingdom Mosaic Regulatory Solutions Full time

    This global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    United Kingdom Mosaic Regulatory Solutions Full time

    This global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...

  • Regulatory Specialist

    1 week 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

    4 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

    4 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

    4 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

    4 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

    1 week ago

    United Kingdom Meet Recruitment Limited Full time

    3 weeks ago Be among the first 25 applicants Senior Consultant Specialising In Regulatory Affairs I am working with a growing pharmaceutical company who provide over-the-counter (OTC) pharmaceutical products dedicated to enhancing the health and well-being of customers. They're currently in the next phase of growth for the company as they're...

  • Regulatory Affairs Specialist

    2 days ago

    United Kingdom Corriculo Recruitment Full time

    Regulatory Affairs Specialist - Fully Remote This is an excellent Regulatory Affairs Specialist / RA Specialist, working for a company with a growing reputation in their field. The successful Regulatory Affairs Specialist / RA Specialist will have hands-on knowledge of FDA regulations, ISO standards & SaMD - as well as proven experience working with...

  • Regulatory Affairs Specialist

    5 hours ago

    United Kingdom Corriculo Recruitment Full time

    Regulatory Affairs Specialist - Fully Remote This is an excellent Regulatory Affairs Specialist / RA Specialist, working for a company with a growing reputation in their field. The successful Regulatory Affairs Specialist / RA Specialist will have hands-on knowledge of FDA regulations, ISO standards & SaMD - as well as proven experience working with...

  • Regulatory Affairs Specialist

    1 month 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 Officer

    1 day ago

    United Kingdom Cpl Life Sciences Full time €35,000 - €37,000

    Job Title: Regulatory Affairs Officer Job Type: Full-time, permanent position Location: Outskirts of Edinburgh, Scotland, UK - 3x a week on site Remuneration: £35,000 to £37,000 + benefits An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department. In this role as a Regulatory...

  • Regulatory Affairs Officer

    8 hours ago

    United Kingdom Cpl Life Sciences Full time €35,000 - €37,000

    Job Title: Regulatory Affairs Officer Job Type: Full-time, permanent position Location: Outskirts of Edinburgh, Scotland, UK - 3x a week on site Remuneration: £35,000 to £37,000 + benefits An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department. In this role as a Regulatory...

  • Regulatory Affairs Interim

    4 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...

  • Regulatory Affairs Specialist

    6 days ago

    United Kingdom Meet Recruitment Limited Full time

    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 all relevant regulations and standards in various...

  • Regulatory Affairs Associate

    3 days ago

    United Kingdom Vibe Recruit Full time €40,000

    We are recruiting for a Regulatory Affairs Associate for a permanent position in Romsey for an industry leading firm that boasts 'Investor In People Gold' status. This is a fantastic opportunity if you ae looking for a role where you can benefit from excellent training, genuine progression and job satisfaction. If you have experience of...

  • Freelance Regulatory Affairs Consultant

    4 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 Officer

    1 month ago

    United Kingdom Hyper Recruitment Solutions Full time

    We are currently looking for a Senior Regulatory Affairs Officer to join a leading Pharmaceutical company based in the Kent area. As the Regulatory Affairs Manager, you will play a pivotal role in managing the life cycle and post-authorisation changes for products within the UK, focusing on CMC, clinical, safety, and product information modifications. Your...

  • Senior Regulatory Affairs Officer

    1 month ago

    United Kingdom Hyper Recruitment Solutions Full time

    We are currently looking for a Senior Regulatory Affairs Officer to join a leading Pharmaceutical company based in the Kent area. As the Regulatory Affairs Manager, you will play a pivotal role in managing the life cycle and post-authorisation changes for products within the UK, focusing on CMC, clinical, safety, and product information modifications. Your...

  • Regulatory Affairs Manager

    2 weeks ago

    United Kingdom Real Staffing Group Full time

    Our client grew into a global health and wellness company providing Pharmaceutical, OTC and medical device products to the market. A world leader in manufacturing and marketing of pharmaceuticals, cosmetics, skin care and health care products. They have operations in 12 major markets, with marketing and distribution agreements in more than 130 countries...