Regulatory Affairs Professional
1 month ago
When our values align, there's no limit to what we can achieve.
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.
-
Regulatory Affairs Manager
6 days ago
Uxbridge, United Kingdom Park Street People Full timeAn innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and early stage development experience to join their team on a 12 month temporary contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the...
-
Regulatory Affairs Manager
4 weeks ago
Uxbridge, United Kingdom Park Street People Full timeAn innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and early stage development experience to join their team on a 12 month temporary contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the...
-
Regulatory Affairs Manager
4 weeks ago
Uxbridge, United Kingdom Park Street People Full timeAn innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and early stage development experience to join their team on a 12 month temporary contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the...
-
Regulatory Affairs Manager
7 days ago
Uxbridge, United Kingdom Park Street People Full timeAn innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and early stage development experience to join their team on a 12 month temporary contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the...
-
Regulatory Affairs Manager
4 weeks ago
Uxbridge, United Kingdom CK Group- Science, Clinical and Technical Full timeCK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company who are based in Uxbridge on a contract basis for 12 months. Company: Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human...
-
Regulatory Affairs Senior Manager
7 days ago
Uxbridge, United Kingdom Park Street People Full timeA global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team. You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products. This is a great opportunity to work with a team who take provide in...
-
Regulatory Affairs Senior Manager
7 days ago
Uxbridge, United Kingdom Park Street People Full timeA global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team.You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products. This is a great opportunity to work with a team who take provide in working...
-
Regulatory Affairs Manager
6 days ago
Uxbridge, United Kingdom i-Pharm Consulting Full timeRegulatory Affairs Manager CMCDuration: 6 month Contract Inside IR35Location: Uxbridge, 3 days on-site per weekHourly Rate: £40-£55 per hour dependent on experience.This role focuses on the critical aspect of Chemistry, Manufacturing, and Controls (CMC) within regulatory affairs. Responsibilities include:Leading global regulatory strategies with a strong...
-
Regulatory Affairs Senior Manager
7 days ago
Uxbridge, United Kingdom Park Street People Full timeA global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team. You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products. This is a great opportunity to work with a team who take provide in...
-
Regulatory Affairs Manager
4 weeks ago
Uxbridge, United Kingdom CK Group- Science, Clinical and Technical Full timeCK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company who are based in Uxbridge on a contract basis for 12 months.Company:Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics....
-
Regulatory Affairs Manager
1 week ago
Uxbridge, United Kingdom i-Pharm Consulting Full timeRegulatory Affairs Manager (Inside IR35)Duration: 12 months (Extention possible)Location: Uxbridge, 3 days on-site per weekHourly Rate: £40-£55 per hour dependant on experience.Overview: Join our dynamic team as a Regulatory Affairs Manager, where you'll support regional regulatory activities for innovative products. As a key member of the Global...
-
Regulatory Affairs Senior Manager
4 days ago
Uxbridge, United Kingdom Park Street People Full timeA global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team.You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products. This is a great opportunity to work with a team who take provide in working...
-
Regulatory Affairs Senior Manager
4 days ago
Uxbridge, United Kingdom Park Street People Full timeA global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team.You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products. This is a great opportunity to work with a team who take provide in working...
-
Regulatory Affairs Senior Manager
4 days ago
Uxbridge, United Kingdom Park Street People Full timeA global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team.You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products. This is a great opportunity to work with a team who take provide in working...
-
Regulatory Affairs Senior Manager
20 hours ago
Uxbridge, United Kingdom Park Street People Full timeA global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team.Please make sure you read the following details carefully before making any applications.You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across...
-
Regulatory Affairs Senior Manager
4 days ago
Uxbridge, United Kingdom Park Street People Full timeA global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team.You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products. This is a great opportunity to work with a team who take provide in working...
-
Regulatory Affairs Manager
4 weeks ago
Uxbridge, United Kingdom CK Group Full timeCK Group are recruiting for a Regulatory Affairs Manager to join a biopharmaceutical company who are based in Uxbridge on a contract basis for 12 months. Company: Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics....
-
Regulatory Affairs Manager
7 days ago
Uxbridge, United Kingdom i-Pharm Consulting Full timeRegulatory Affairs Manager (Inside IR35)Duration: 12 months (Extention possible)Location: Uxbridge, 3 days on-site per weekHourly Rate: £40-£55 per hour dependant on experience.Overview: Join our dynamic team as a Regulatory Affairs Manager, where you'll support regional regulatory activities for innovative products. As a key member of the Global...
-
Regulatory Affairs Manager
1 week ago
Uxbridge, United Kingdom i-Pharm Consulting Full timeRegulatory Affairs Manager (Inside IR35)Duration: 12 months (Extention possible)Location: Uxbridge, 3 days on-site per weekHourly Rate: £40-£55 per hour dependant on experience.Overview: Join our dynamic team as a Regulatory Affairs Manager, where you'll support regional regulatory activities for innovative products. As a key member of the Global...
-
Regulatory Affairs Manager
7 days ago
Uxbridge, United Kingdom i-Pharm Consulting Full timeRegulatory Affairs Manager (Inside IR35)Duration: 12 months (Extention possible)Location: Uxbridge, 3 days on-site per weekHourly Rate: £40-£55 per hour dependant on experience.Overview: Join our dynamic team as a Regulatory Affairs Manager, where you'll support regional regulatory activities for innovative products. As a key member of the Global...
