Senior Regulatory Executive, CMC in Uxbridge or Ware
- Recruiter
- CK GROUP
- Location
- Greater London
- Salary
- Competitive
- Posted
- 28 Jun 2019
- Closes
- 26 Jul 2019
- Sectors
- Scientific & Pharmaceutical
- Contract Type
- Permanent
- Hours
- Full Time
CK Group is recruiting for a Senior Regulatory Executive to join a company in the Pharmaceutical industry at their site based in either Uxbridge or Ware on a 12 month contract basis initially.
The Company:
As a global healthcare company, they take on some of the world's biggest healthcare challenges. By delivering a sustainable business, they provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. They have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. They are committed to widening access to their products, so more people can benefit, no matter where they live in the world or what they can afford to pay.
The Location:
The position comes with the opportunity to work at either our clients site in Uxbridge (West London) or Ware (Hertfordshire). Additionally, there will some flexibility with starting and finishing time at work (core hours of 10am-4pm) and up to 2 days remote working a week at the managers discretion.
The Role:
This position will be directly responsible for managing CMC post-approval activities for a biopharmaceutical product approved in US, EU, Japan, and ROW markets. The individual will work collaboratively and proactively within the CMC project team and across multiple functional areas to manage the response activities to develop the strategy, scope, and content of the CMC sections of the responses.
The main responsibilities of this position include the following:
- Provide guidance to functional area authors/reviewers with regards to submission and dossier requirements. Understand, interpret, and advise on regulations, guidelines, procedures, and policies relating to the development, manufacture, and successful global registration of biopharmaceutical products.
- Directly manage completion of multiple dossier components to meet project timelines.
- Review documents and dossier components to assure that technical/regulatory strategy and data integrity processes are followed.
- Accountable for ensuring that dossier components meet global/regional standards for content, quality, and regulatory requirements.
- Work closely with project team members and CMC regulatory team to produce high quality submissions.
- Work closely with project management and CMC regulatory team to execute plans for managing workload within assigned project objectives through efficient resource utilization and within designated timeframes.
- Identify, document, and communicate regulatory project risks that could impact timeline and quality of regulatory submissions.
- Organize and archive CMC dossier components and supporting documents in appropriate document management systems.
- Interface with regulatory operations staff to coordinate dossier review, approval and publishing activities.
Your Background:
To be considered for this role you should have the following key skills, knowledge and experience:
- Bachelor's degree in life sciences or related scientific discipline.
- Prior experience in pharmaceutical or biotechnology drug development, with direct involvement in CMC-related activities and functions.
- Experience in authoring CMC content for regulatory submissions is required.
- Strong technical writing skills and attention to detail.
- Strong verbal communications skills and demonstrated ability to work in a matrix/team environment.
- Ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
- Strong computer skills in Microsoft Office applications with the ability to learn new applications quickly and easily.
- CMC regulatory affairs experience with biopharmaceutical products.
- Basic knowledge of FDA and EU CMC regulatory requirements.
- Experience with preparation of CMC submissions (INDs, IMPDs, amendments, BLA/MAA).
- Ability to track multiple dossier components and manage successful completion of components for submissions. Understanding of dossier development and formatting requirements, document and dossier management.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45917 in all correspondence.
The Company:
As a global healthcare company, they take on some of the world's biggest healthcare challenges. By delivering a sustainable business, they provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. They have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. They are committed to widening access to their products, so more people can benefit, no matter where they live in the world or what they can afford to pay.
The Location:
The position comes with the opportunity to work at either our clients site in Uxbridge (West London) or Ware (Hertfordshire). Additionally, there will some flexibility with starting and finishing time at work (core hours of 10am-4pm) and up to 2 days remote working a week at the managers discretion.
The Role:
This position will be directly responsible for managing CMC post-approval activities for a biopharmaceutical product approved in US, EU, Japan, and ROW markets. The individual will work collaboratively and proactively within the CMC project team and across multiple functional areas to manage the response activities to develop the strategy, scope, and content of the CMC sections of the responses.
The main responsibilities of this position include the following:
- Provide guidance to functional area authors/reviewers with regards to submission and dossier requirements. Understand, interpret, and advise on regulations, guidelines, procedures, and policies relating to the development, manufacture, and successful global registration of biopharmaceutical products.
- Directly manage completion of multiple dossier components to meet project timelines.
- Review documents and dossier components to assure that technical/regulatory strategy and data integrity processes are followed.
- Accountable for ensuring that dossier components meet global/regional standards for content, quality, and regulatory requirements.
- Work closely with project team members and CMC regulatory team to produce high quality submissions.
- Work closely with project management and CMC regulatory team to execute plans for managing workload within assigned project objectives through efficient resource utilization and within designated timeframes.
- Identify, document, and communicate regulatory project risks that could impact timeline and quality of regulatory submissions.
- Organize and archive CMC dossier components and supporting documents in appropriate document management systems.
- Interface with regulatory operations staff to coordinate dossier review, approval and publishing activities.
Your Background:
To be considered for this role you should have the following key skills, knowledge and experience:
- Bachelor's degree in life sciences or related scientific discipline.
- Prior experience in pharmaceutical or biotechnology drug development, with direct involvement in CMC-related activities and functions.
- Experience in authoring CMC content for regulatory submissions is required.
- Strong technical writing skills and attention to detail.
- Strong verbal communications skills and demonstrated ability to work in a matrix/team environment.
- Ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.
- Strong computer skills in Microsoft Office applications with the ability to learn new applications quickly and easily.
- CMC regulatory affairs experience with biopharmaceutical products.
- Basic knowledge of FDA and EU CMC regulatory requirements.
- Experience with preparation of CMC submissions (INDs, IMPDs, amendments, BLA/MAA).
- Ability to track multiple dossier components and manage successful completion of components for submissions. Understanding of dossier development and formatting requirements, document and dossier management.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45917 in all correspondence.