Head Of Regulatory Affairs
- Recruiter
- Clearwater People Solutions
- Location
- London
- Salary
- 80000.00 - 85000.00 GBP Annual + extensive benefits package
- Posted
- 13 Jan 2017
- Closes
- 20 Jan 2017
- Sectors
- Scientific & Pharmaceutical
- Contract Type
- Permanent
- Hours
- Full Time
Head of Regulatory Affairs
This is a great opportunity to work at a leading CTG (Cell and Gene therapy) organisation as Head of Regulatory Affairs based in London. The role is based a ten-minute walk from London Bridge station in the heart of the Capital city.
As Head of Regulatory Affairs you will be responsible for the overseeing of products (Cell and Gene Therapy) into early clinical trials, providing clinical, technical and manufacturing regulatory expertise. As Head of Regulatory Affairs you will be key source of regulatory understanding for other management, and to the Regulatory Group. There will be a strong focus on supporting clinical trial initiatives and therefore requires strong ATMP experience in clinical trial submission.
The successful candidate will have a comprehensive understanding of the industry and demonstrable experience within this role, or similar level position.
Key Duties/Responsibilities:
- Key Source of Regulatory knowledge supporting clinical trial initiatives.
- Support in development of CMC and Regulatory Strategy.
- Overseeing submission of regulatory documentation (briefing documents, CTAs, INDs, safety reports and annual reports).
- Ensuring the close liaison with relevant internal departments to ensure proposed developments are fit for purpose.
- The ability and experience of working closely with internal Compliance Teams and senior regulatory individuals.
- Understanding of the UK, EU and FDA protocols.
Experience and Qualifications:
- 10+ Years' proven experience in a regulatory role (advanced therapy, cell-based preferred).
- Knowledge of CMC and GMP requirements for ATMPs.
- Experience evaluating and implementing regulatory strategies and any issues that may arise within biotechnology, biological therapies and preferably, advanced therapies
- Ability to lead regulatory aspects of development strategy
- Prior experience delivering high-quality regulatory documents
- Demonstrable leadership of IND and CTA processes
- Line Management experience
Highly Desirable:
- Registration of Cell and Gene therapies for clinical trial throughout the UK or US
What is Offered:
- Full-time career opportunity with career progression
- Market-leading salary will be offered depending on level of experience and skills
- Permanent contract of employment with company perks and benefits
Why this Vacancy is right for you:
- Established and successful company.
- Investment in employee development.
Please send your application* with your most recent CV today via Pharmiweb. To find out more about this career opportunity please call Michael or email (see below) detailing your interest.
If this role is not right for you, please contact us to discuss what you are looking for.
*Applicants who have not had a response within two weeks should assume their application has been unsuccessful.
Clearwater People Solutions are proud to offer a service based on a quality and personalised approach. We work diligently on behalf of our Candidates to find the right role that you and your specialist skill set deserve. Our consultative, honest approach combined with our integrity and full qualification of each-and-every requirement we work make us a perfect partner for you in your search for the ideal position.
At Clearwater: your Career is our Job. We look forward to hearing from you.
Key Words: - IND/CTA/CMC/Regualtory Affairs/Cell Therapy/Gene Therapy/FDA/ATMP
This is a great opportunity to work at a leading CTG (Cell and Gene therapy) organisation as Head of Regulatory Affairs based in London. The role is based a ten-minute walk from London Bridge station in the heart of the Capital city.
As Head of Regulatory Affairs you will be responsible for the overseeing of products (Cell and Gene Therapy) into early clinical trials, providing clinical, technical and manufacturing regulatory expertise. As Head of Regulatory Affairs you will be key source of regulatory understanding for other management, and to the Regulatory Group. There will be a strong focus on supporting clinical trial initiatives and therefore requires strong ATMP experience in clinical trial submission.
The successful candidate will have a comprehensive understanding of the industry and demonstrable experience within this role, or similar level position.
Key Duties/Responsibilities:
- Key Source of Regulatory knowledge supporting clinical trial initiatives.
- Support in development of CMC and Regulatory Strategy.
- Overseeing submission of regulatory documentation (briefing documents, CTAs, INDs, safety reports and annual reports).
- Ensuring the close liaison with relevant internal departments to ensure proposed developments are fit for purpose.
- The ability and experience of working closely with internal Compliance Teams and senior regulatory individuals.
- Understanding of the UK, EU and FDA protocols.
Experience and Qualifications:
- 10+ Years' proven experience in a regulatory role (advanced therapy, cell-based preferred).
- Knowledge of CMC and GMP requirements for ATMPs.
- Experience evaluating and implementing regulatory strategies and any issues that may arise within biotechnology, biological therapies and preferably, advanced therapies
- Ability to lead regulatory aspects of development strategy
- Prior experience delivering high-quality regulatory documents
- Demonstrable leadership of IND and CTA processes
- Line Management experience
Highly Desirable:
- Registration of Cell and Gene therapies for clinical trial throughout the UK or US
What is Offered:
- Full-time career opportunity with career progression
- Market-leading salary will be offered depending on level of experience and skills
- Permanent contract of employment with company perks and benefits
Why this Vacancy is right for you:
- Established and successful company.
- Investment in employee development.
Please send your application* with your most recent CV today via Pharmiweb. To find out more about this career opportunity please call Michael or email (see below) detailing your interest.
If this role is not right for you, please contact us to discuss what you are looking for.
*Applicants who have not had a response within two weeks should assume their application has been unsuccessful.
Clearwater People Solutions are proud to offer a service based on a quality and personalised approach. We work diligently on behalf of our Candidates to find the right role that you and your specialist skill set deserve. Our consultative, honest approach combined with our integrity and full qualification of each-and-every requirement we work make us a perfect partner for you in your search for the ideal position.
At Clearwater: your Career is our Job. We look forward to hearing from you.
Key Words: - IND/CTA/CMC/Regualtory Affairs/Cell Therapy/Gene Therapy/FDA/ATMP