AX-7255 CMC Regulatory Affairs Director
Are you an experienced CMC Regulatory Affairs professional looking to achieve a Director level positon? AXESS have partnered with a leading global biopharma to seek a Director to manage CMOs and strategic activities.
Global specialty-driven biotechnology group
Offer products in oncology and endocrinology amongst others
Launches anticipated over the next 2 years
The Director, CMC Regulatory Affairs will determine the required global regulatory CMC strategy to support the department and lead regulatory CMC team to deliver.
Overall responsibility and leadership for the strategy and execution of CMC regulatory filings including authoring, coordination, review and approval for the assigned product portfolio, working closely with vendors and partner companies to ensure alignment.
Ensure that an effective CMC Regulatory function is developed so that the quality of the Company’s products are enhanced or maintained, the patients’ interests are protected and company’s objectives are met.
Managing activities for the portfolio and what is required in relation to external manufacturing, ensuring thorough communication through the CMC regulatory process, developing related procedures to ensure compliance.
QUALIFICATIONS / EXPERIENCE REQUIRED:
Bachelor's degree in Science
Substantial experience in the preparation and submission of CMC filings (module 3 and 2.3) in a US and European environment
Experience with other global markets such as Australia, Canada, Switzerland and Emerging markets advantageous.
Proven significant experience in the regulatory CMC biologics, small molecules and High Potency field.
Particularly, sound technical knowledge of the manufacture of pharmaceuticals and sterile biological/HiPo drug substances and drug products and appropriate understanding of all CMC disciplines.
Experience with orphan drug designation, paediatric licences and Radiation Therapies is desirable.
Sound experience in managing biological product site transfers and associated comparability plans.
Strong regulatory writing experience and familiarity with eCTD formats and publishing support functions.
Experience leading scientific advice meetings
Line Management of remote teams up to Manager Level experience
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300 quoting reference 7255.
To apply, please click the APPLY ONLINE button.
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