CMC Regulatory Affairs Manager
Posted on Feb 15, 2020 by Real Staffing Group
A Global Leader in Biopharmaceutical industry are seeking for a CMC Regulatory Affairs Manager to join their regulatory operations team based in Dublin.
This is an exciting opportunity to work as part of an agile and patient centric company who strive to improve lives through science and compassion.
Your New Role
As the CMC Regulatory Manager you will be responsible for developing the Chemistry, Manufacturing and Control regulatory strategies for development compounds and marketed products.
Alongside this you will look after the coordination of all aspects of CMC regulatory submissions for assigned projects, providing guidance on post-approval changes, and drafting/editing submission documents. You will be reporting into the Director of CMC Regulatory Affairs.
Your New Company
A company that is focused on improving patient's lives by identifying, developing, acquiring and commercialising differentiated and accessible medicines that address unmet medical needs.
The company is headquartered in Dublin and has a portfolio of medicines through its orphan, primary care and rheumatology business units and defines success as the number of lives touched, the number of lives changed, the number of lives saved.
Your Duties and Responsibilities as CMC Regulatory Affairs Manager
- Contribute with technical writing for all major regulatory submissions (eg, INDs, CTAs, NDAs, BLAs, MAAs), outlining potential regulatory risks and proposals for mitigation strategies.
- Formulate, contribute and present CMC regulatory strategies, ensuring alignment with corporate objectives, in conjunction with Tech. Ops, R&D, Commercial and other internal stakeholders.
- Coordinate and collaborate on the preparation of CMC components of regulatory submissions.
- Assist in preparation of meeting request, briefing book, and subsequent interaction for CMC-related topics with Health Authorities.
- Maintain a knowledge base of current and emerging CMC regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues.
Your Education & Experience
- BSc. in related scientific discipline (biology, chemistry, biochemistry, immunology, pharmacy).
- 4-6 year's Pharmaceutical industry experience with at least 3 year's experience in a CMC regulatory position.
- Knowledge and experience with the manufacture and testing of both biological and small molecule products.
- Understanding of relevant CMC drug development regulations and guidelines.
Your Skills & Competencies
- Ability to effectively prioritise and manage a diversified workload, often to strict deadlines.
- Strong interpersonal skills, a professional approach with excellent written and verbal communication skills.
- Good judgement and strong initiative.
What's in it for you?
And further to this the opportunity in joining an award winning Biopharmaceutical Company that has been recognised for it's outstanding company culture and workplace best practices, you will receive a very competitive salary & benefits package.
Your Next Step
If this sounds like the right role for you, please reply with an up to date CV for immediate consideration.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales
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