Senior Regulatory Affairs Officer

1 month ago

Kent, 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 Officer, 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 expertise will be instrumental in writing, compiling, and publishing dossiers for UK National & EU submissions, ensuring compliance with regulatory requirements.


KEY DUTIES AND RESPONSIBILITIES:


Your duties as the Senior Regulatory Affairs Officer will be varied however the key duties and responsibilities are as follows:


1. Oversee dossier compilation and submission for UK and EU markets.


2. Liaise with regulatory bodies and manage communication regarding variations.


3. Develop product information and approve artwork for regulatory compliance.


4. Ensure that CMC practices align with regulatory standards, developing clear justifications for new product licenses and variations.


ROLE REQUIREMENTS:


To be successful in your application to this exciting role as the Regulatory Affairs Officer, we are looking to identify the following on your profile and past history:


1. Educated to degree level in science or equivalent experience.


2. Proven experience in Regulatory Affairs within the Pharmaceutical industry.


3. Strong communication and project management skills.


4. Proficiency in MS Office suite and regulatory submission portals.


Key Words: Regulatory Affairs Officer | Pharmaceutical | Life Cycle Management | CMC | Clinical | Safety | Product Information | Dossier | Submission | Variations | MA Transfer | eCTD | EMC | MHRA | CESP | Artwork | Pharmacovigilance | Generics |

  • Senior Regulatory Affairs Officer

    3 months ago

    KENT, United Kingdom Hyper Recruitment Solutions LTD 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 Officer, 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 Manager, Regulatory Affairs

    6 hours ago

    Kent, United Kingdom Blackfield Associates Full time

    Job Title: Senior Manager, Regulatory AffairsJob Summary:Blackfield Associates is seeking a highly experienced Senior Manager, Regulatory Affairs to lead our European Regulatory Affairs team. As a key member of our organization, you will be responsible for ensuring all regulatory and compliance activities across Europe are effectively managed, supporting the...

  • Senior Manager, Regulatory Affairs

    3 hours ago

    Kent, United Kingdom Blackfield Associates Full time

    Job Title: Senior Manager, Regulatory AffairsJob Summary:Blackfield Associates is seeking a highly experienced Senior Manager, Regulatory Affairs to lead our European Regulatory Affairs team. As a key member of our organization, you will be responsible for ensuring all regulatory and compliance activities across Europe are effectively managed, supporting the...

  • Senior Manager Regulatory Affairs

    3 days ago

    Kent, United Kingdom Blackfield Associates Full time

    Blackfield are pleased to be partnered with an international business, with a requirement for a Senior Manager, European Regulatory Affairs, to ensures all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of products.This role leads the European Regulatory Affairs team, partners with...

  • Senior Manager Regulatory Affairs

    3 days ago

    Kent, United Kingdom Blackfield Associates Full time

    Blackfield are pleased to be partnered with an international business, with a requirement for a Senior Manager, European Regulatory Affairs, to ensures all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of products.This role leads the European Regulatory Affairs team, partners with...

  • Senior Manager Regulatory Affairs

    3 days ago

    Kent, United Kingdom Blackfield Associates Full time

    Blackfield are pleased to be partnered with an international business, with a requirement for a Senior Manager, European Regulatory Affairs, to ensures all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of products. This role leads the European Regulatory Affairs team, partners with...

  • Senior Manager Regulatory Affairs

    16 hours ago

    Kent, United Kingdom Blackfield Associates Full time

    Blackfield are pleased to be partnered with an international business, with a requirement for a Senior Manager, European Regulatory Affairs, to ensures all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of products. This role leads the European Regulatory Affairs team, partners...

  • Senior Manager Regulatory Affairs

    3 days ago

    Kent, United Kingdom Blackfield Associates Full time

    Blackfield are pleased to be partnered with an international business, with a requirement for a Senior Manager, European Regulatory Affairs, to ensures all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of products.This role leads the European Regulatory Affairs team, partners with...

  • Senior Manager Regulatory Affairs

    13 hours ago

    Kent, United Kingdom Blackfield Associates Full time

    Blackfield are pleased to be partnered with an international business, with a requirement for a Senior Manager, European Regulatory Affairs, to ensures all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of products. This role leads the European Regulatory Affairs team, partners...

  • Senior Manager Regulatory Affairs

    23 hours ago

    Kent, United Kingdom Blackfield Associates Full time

    Blackfield are pleased to be partnered with an international business, with a requirement for a Senior Manager, European Regulatory Affairs, to ensures all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of products.This role leads the European Regulatory Affairs team, partners with...

  • Senior Manager Regulatory Affairs

    3 days ago

    Kent, United Kingdom Blackfield Associates Full time

    Blackfield are pleased to be partnered with an international business, with a requirement for a Senior Manager, European Regulatory Affairs, to ensures all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of products.This role leads the European Regulatory Affairs team, partners with...

  • Senior Manager Regulatory Affairs Specialist

    2 days ago

    Kent, United Kingdom Blackfield Associates Full time

    Job DescriptionBlackfield Associates is seeking a highly skilled Senior Manager Regulatory Affairs to lead our European Regulatory Affairs team and ensure compliance with EU regulations.This role is crucial for the success of our company in the European market, and we are looking for a seasoned professional with extensive experience in regulatory affairs.Key...

  • Senior Manager Regulatory Affairs Specialist

    2 days ago

    Kent, United Kingdom Blackfield Associates Full time

    Job DescriptionBlackfield Associates is seeking a highly skilled Senior Manager Regulatory Affairs to lead our European Regulatory Affairs team and ensure compliance with EU regulations.This role is crucial for the success of our company in the European market, and we are looking for a seasoned professional with extensive experience in regulatory affairs.Key...

  • Senior Manager Regulatory Affairs

    2 days ago

    Kent Street, United Kingdom Blackfield Associates Full time

    Blackfield are pleased to be partnered with an international business, with a requirement for a Senior Manager, European Regulatory Affairs, to ensures all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of products.This role leads the European Regulatory Affairs team, partners with...

  • Senior Manager, Regulatory Affairs Lead

    2 days ago

    Kent, United Kingdom Blackfield Associates Full time

    Job DescriptionBlackfield Associates is pleased to be partnered with an international business, with a requirement for a Senior Manager, European Regulatory Affairs, to ensure all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of products.This role leads the European Regulatory...

  • Senior Manager, Regulatory Affairs Lead

    2 days ago

    Kent, United Kingdom Blackfield Associates Full time

    Job DescriptionBlackfield Associates is pleased to be partnered with an international business, with a requirement for a Senior Manager, European Regulatory Affairs, to ensure all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of products.This role leads the European Regulatory...

  • Senior Manager Regulatory Affairs Specialist

    2 days ago

    Kent, United Kingdom Blackfield Associates Full time

    Job DescriptionBlackfield Associates is seeking a highly skilled Senior Manager to lead our European Regulatory Affairs team. As a key member of our organization, you will be responsible for ensuring all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of our products.This role will...

  • Senior Manager Regulatory Affairs Specialist

    2 days ago

    Kent, United Kingdom Blackfield Associates Full time

    Job DescriptionBlackfield Associates is seeking a highly skilled Senior Manager to lead our European Regulatory Affairs team. As a key member of our organization, you will be responsible for ensuring all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of our products.This role will...

  • Regulatory Affairs Director

    6 days ago

    kent, United Kingdom Blackfield Associates Full time

    Job DescriptionBlackfield Associates is seeking a seasoned professional to lead our European Regulatory Affairs team. As the Head of Regulatory Affairs and Compliance, you will be responsible for ensuring all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of our products.Key...

  • Head of Regulatory Affairs

    7 days ago

    Kent, United Kingdom Blackfield Associates Full time

    Blackfied are pleased to be partnered with an international business, with a requirement for a Head of European Regulatory Affairs, to ensures all regulatory and compliance activities across Europe are effectively managed, supporting the distribution, R&D, and marketing of products. This role leads the European Regulatory Affairs team, partners with the...