CMC Regulatory Professional, United Kingdom - L
- Experience Level
- Experienced (non-manager)
We are currently working with one of our large pharma clients to find them two experienced CMC professionals for biotech products and highly skilled in authoring CMC modules and drive regulatory strategies.
The successful candidate will provide support, or lead as assigned, regulatory CMC submissions for all products in development.
Small Molecule Experience is a pre-requisite for one of the roles available.
Education, Experience and Skills
- 5-8 years relevant experience in the pharmaceutical industry or a regulatory authority in a CMC review capacity. Understanding of Regulatory Affairs CMC and deep professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field
- Proven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical entities
- Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and post-approval products
- Experience of direct communication and negotiation with regulatory agencies on CMC matters
- Experience of participating in regulatory agency meetings on CMC matters
Knowledge of GMP requirements and standard systems (e.g. change management systems and tools)
- Demonstrated competence in contributing on cross-functional teams and operating within a matrix organisational structure
The Benefits of Working for TalentSource in the UK
- Pension contribution
- Life assurance
- 25 days holiday
- Child care vouchers
- Eye test vouchers
- Seniority bonus
- Car allowance for defined roles
- Dedicated Line Manager
- Monthly meetings with line manager
- Full performance and development process with end of year reviews
- Team events and end of year party
- Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
- Employee satisfaction survey - your feedback is important for continuous improvement
Who will you be working for?
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.
About TalentSource Life Sciences
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002404
or please contact Rocio.EgeaMota@cromsource.com for more information.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Keywords: CMC Regulatory Professional, CMC
Skills: Biotech, Global Regulatory Affairs, GMP, Manufacturing, Quality Assurance, Quality Control, Regulatory Location: United Kingdom Share:
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