Overview

Reference Number: JO-2003-447896
Regulatory CMC, Senior Director
Rate: Negotiable
Job Type: Permanent
Location: Switzerland

Role: Regulatory CMC, Senior Director
Location: (Zug, Switzerland)
Employment: Permanent, Full Time
Reference number:

Company
Our client is a global Biotechnology company whose main focus is Gene Therapy; they are currently seeking a Senior Director in Regulatory CMC for advanced therapy medicinal products (ATMPs) who will be responsible for the global development and submission of regulatory dossiers for gene therapy projects for their severe genetic diseases franchise.

Main responsibilities
Deliver regulatory CMC strategic leadership to support development of multiple innovative gene therapy products for the treatment of severe genetic diseases
Lead, mentor and grow a team of regulatory CMC professional
Manage and implement planning, preparation and submission of high-quality CMC related applications with a focus on the EU/EMEA region
Ensure that CMC-related applications and/or sections, including IMPDs/INDs, investigator brochures, scientific advice requests, agency briefing documents, and MAAs or BLAs are complete, well written, and meet all relevant requirements
Lead negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators globally; prepare and submit responses to CMC questions; support interactions with regulatory agencies during GMP and pre-approval inspections
Effectively communicate regulatory CMC strategy
Drive adherence to CMC regulatory guidelines relevant for the development of gene therapy products; review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals
Assess proposed manufacturing process changes and provide strategic regulatory guidance to enable global implementation

Knowledge, Experience & Skills:
Eligibility to work in the EU
Masters degree in life sciences in biochemistry, chemistry, biology or related pharmaceutical fields including biochemical engineering; higher degree, such as a PhD is desirable
12+ years of relevant biopharmaceutical industry experience, with 10+ years experience in CMC-focused Regulatory Affairs for biologics or 5+ years experience in ATMPs
Prior experience and a successful track record within the biotechnology and/or pharmaceutical industry in successful preparation and submission of IMPDs/INDs, Scientific Advice, MAAs/BLAs, post-approval life cycle management and supporting GMP inspections
Strong knowledge of current Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines including ICH, EMA and FDA guidelines
Strong leadership qualities including strategic thinking, innovation, people management, mentoring, scaling and collaboration

If you are interested in discussing this role further, then please email your CV to amani.yousef@regulatoryprofessionals.com or call Amani on 01189 522 797 to arrange a confidential discussion.

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