Regulatory Affairs Specialist

3 weeks ago

Leeds, Leeds, United Kingdom Lifelancer Full time
Principal Regulatory Affairs Consultant

Parexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecules. This is a unique opportunity to showcase your technical skills, specialist knowledge, and mentorship abilities.

Key Responsibilities:
  • Provide overall project leadership and ensure the project's successful planning and set-up.
  • Maintain accurate project reporting and deliver to meet client expectations.
  • Develop and implement submission strategies and plans for post-approval CMC activities, including variations, renewals, market expansions, and annual reports.
  • Assess change controls and provide regulatory assessments of quality changes in production and quality control.
  • Review study reports from the quality control and production departments to ensure compliance with regulatory requirements.
  • Coordinate submission preparation with various departments, including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies.
  • Write and review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities.
  • Collaborate within a team environment to deliver project requirements. Prioritize workloads, both for yourself and the project team, to achieve project scope and objectives.
  • Deliver engaging presentations at seminars and industry group meetings. Author articles for industry publications, demonstrating expertise and showcasing Parexel's capabilities.
  • Identify, escalate, and mitigate risks associated with regulatory procedures and activities.
  • Mentor and coach more junior members of the team.
  • Collaborate with Account Management to prospect and leverage new business opportunities.
  • Effectively communicate Parexel's service offerings, demonstrating our capability to support client needs.
Experience and Skills Required:
  • University-level education in Life Sciences or equivalent by experience.
  • Extensive experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry.
  • Strong understanding of CMC and post-approval regulatory requirements.
  • Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations.
  • Knowledge of small molecule processes.
  • Proficient account planning and support abilities.
  • Networking skills to expand professional connections.
  • Team spirit, flexibility, accountability, and organizational skills.
  • Strong project leadership and management knowledge.
  • Strong business acumen for analysis and decision-making.
  • Self-confidence and control in professional engagements.
  • Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued.
  • Fluent in English (written and spoken).

  • Regulatory Affairs Specialist

    1 week ago

    Leeds, Leeds, United Kingdom Seven Life Sciences Full time

    Job Title: Regulatory Affairs SpecialistJob Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Seven Life Sciences. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for medical devices.Key Responsibilities:Review and update technical files for medical...

  • Regulatory Affairs Specialist

    2 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Senior Regulatory Affairs Manager/ConsultantWe are seeking a seasoned Senior Regulatory Affairs Manager/Consultant to join our team at Lifelancer. As a key member of our regulatory affairs team, you will be responsible for providing expert guidance on regulatory strategies, ensuring compliance with EU guidelines, and managing client relationships.Key...

  • Regulatory Affairs Specialist

    2 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Senior Regulatory Affairs Manager/ConsultantWe are seeking a seasoned Senior Regulatory Affairs Manager/Consultant to join our team at Lifelancer. As a key member of our regulatory affairs team, you will be responsible for providing expert guidance on regulatory strategies, ensuring compliance with EU guidelines, and managing client relationships.Key...

  • Regulatory Affairs Specialist

    3 weeks ago

    Leeds, Leeds, United Kingdom NHS England Full time

    Regulatory Affairs Specialist OpportunityAn exciting opportunity has arisen for a skilled Regulatory Affairs Specialist to join the patient safety team within the Transformation Directorate's Digital Clinical Informatics (DCI) team at NHS England.The role will support the quality and regulatory team in implementing and maintaining NHS-England's quality...

  • Regulatory Affairs Specialist

    3 weeks ago

    Leeds, Leeds, United Kingdom NHS England Full time

    Regulatory Affairs Specialist OpportunityAn exciting opportunity has arisen for a skilled Regulatory Affairs Specialist to join the patient safety team within the Transformation Directorate's Digital Clinical Informatics (DCI) team at NHS England.The role will support the quality and regulatory team in implementing and maintaining NHS-England's quality...

  • Regulatory Affairs Specialist

    3 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Senior Regulatory Affairs Manager/ConsultantWe are seeking a seasoned Senior Regulatory Affairs Manager/Consultant to join our team at Lifelancer. As a key member of our regulatory affairs team, you will be responsible for providing expert guidance on regulatory strategies, ensuring compliance with EU guidelines, and managing client relationships.This is a...

  • Regulatory Affairs Specialist

    3 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Senior Regulatory Affairs Manager/ConsultantWe are seeking a seasoned Senior Regulatory Affairs Manager/Consultant to join our team at Lifelancer. As a key member of our regulatory affairs team, you will be responsible for providing expert guidance on regulatory strategies, ensuring compliance with EU guidelines, and managing client relationships.This is a...

  • Regulatory Affairs Specialist

    2 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Principal Regulatory Affairs ConsultantParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecules. The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth...

  • Regulatory Affairs Specialist

    2 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Principal Regulatory Affairs ConsultantParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecules. The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Leeds, Leeds, United Kingdom William Hill Full time

    Senior Regulatory Affairs SpecialistWe are seeking an experienced professional to lead our regulatory affairs efforts. As a Senior Regulatory Affairs Specialist, you will be responsible for ensuring that our company adheres to all relevant regulations, industry standards, and internal policies.Key Responsibilities:Oversee compliance strategies and coordinate...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Leeds, Leeds, United Kingdom William Hill Full time

    Senior Regulatory Affairs SpecialistWe are seeking an experienced professional to lead our regulatory affairs efforts. As a Senior Regulatory Affairs Specialist, you will be responsible for ensuring that our company adheres to all relevant regulations, industry standards, and internal policies.Key Responsibilities:Oversee compliance strategies and coordinate...

  • Regulatory Affairs Specialist

    7 days ago

    Leeds, Leeds, United Kingdom Seven Life Sciences Full time

    **Job Title:** Regulatory SpecialistAt Seven Life Sciences, we are seeking a highly skilled Regulatory Specialist to join our Quality and Regulatory team. The successful candidate will be responsible for maintaining compliance with ISO 13485, Medical Device Directive 93/42/EEC, and Regulation (EU) 2017/745 (EU MDR).**Key Responsibilities:**Review, update,...

  • Regulatory Affairs Specialist

    4 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Job Title: Principal Regulatory Affairs ConsultantParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. The ideal candidate will possess strong regulatory affairs experience,...

  • Regulatory Affairs Specialist

    3 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Job Title: Principal Regulatory Affairs ConsultantParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. The ideal candidate will possess strong regulatory affairs experience,...

  • Regulatory Affairs Specialist

    4 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Job Title: Principal Regulatory Affairs ConsultantParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. The ideal candidate will possess strong regulatory affairs experience,...

  • Regulatory Affairs Specialist

    3 weeks ago

    Leeds, Leeds, United Kingdom Lifelancer Full time

    Job Title: Principal Regulatory Affairs ConsultantParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. The ideal candidate will possess strong regulatory affairs experience,...

  • Regulatory Affairs Specialist

    3 weeks ago

    Leeds, Leeds, United Kingdom Pharmiweb Full time

    Regulatory Affairs ProfessionalWe are seeking a highly skilled Regulatory Affairs Professional to join our team at Pharmiweb. As a key member of our regulatory team, you will be responsible for providing leadership in all regulatory and submissions-related aspects of clinical trials.Key Responsibilities:Provide guidance on submissions strategies and ensure...

  • Regulatory Affairs Specialist

    3 weeks ago

    Leeds, Leeds, United Kingdom Pharmiweb Full time

    Regulatory Affairs ProfessionalWe are seeking a highly skilled Regulatory Affairs Professional to join our team at Pharmiweb. As a key member of our regulatory team, you will be responsible for providing leadership in all regulatory and submissions-related aspects of clinical trials.Key Responsibilities:Provide guidance on submissions strategies and ensure...

  • Regulatory Affairs Specialist

    4 weeks ago

    Leeds, Leeds, United Kingdom CTI Clinical Trial and Consulting Services Full time

    Principal Regulatory Affairs ConsultantParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified professional with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecules. The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval...

  • Regulatory Affairs Specialist

    4 weeks ago

    Leeds, Leeds, United Kingdom CTI Clinical Trial and Consulting Services Full time

    Principal Regulatory Affairs ConsultantParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified professional with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecules. The ideal candidate will possess strong regulatory affairs experience, project management skills, and in-depth knowledge of post-approval...