Job Title: Regulatory Affairs Sr. Manager (EU)
Responsible to: VP, Global Regulatory Affairs
Responsible for: No direct reports
A specialist Cell and Gene Therapy organisation at the forefront of developing products for clinical use is currently looking for a Regulatory Affairs Senior Manager to join the team at a very exciting time in the company’s expansion. You will play an important role in preparing regulatory submissions and ensuring they are granted and maintained in support of the Company’s business objectives. You will represent the regulatory function on assigned product teams and assist with the development and execution of regulatory strategies for Cell Medica products. You will also play an important role in preparing meeting packages and coordinating regulatory meetings and communications with European competent authorities.
• Prepare and submit clinical trial
applications, substantial amendments, regulatory responses, orphan drug
designation requests and maintenance, PIPs, and MAAs to meet company goals and
timelines. Must be able to write significant sections of regulatory submissions
with input from internal teams and consultants.
• Schedule, prepare meeting packages
for, and coordinate scientific advice meetings with regulatory authorities.
• Represent regulatory affairs function
within cross-functional product development teams.
• Act as a company expert in EU Regulatory
Affairs, providing updates, support and education as required.
• Act as primary contact to EU
all regulatory agency compliance materials to guarantee accuracy, timeliness,
comprehensiveness, and adherence to regulatory standards.
current knowledge of relevant EU regulations including proposed and final rules
and communicate changes to internal team.
• Liaise with external collaborators
and manage external resources e.g. CROs, consultants
• Contribute to the global regulatory
function and organisation of company regulatory data (SOPs, trackers,
• Play an instrumental role in the
global regulatory affairs function through active participation and
• Involved with development of
regulatory strategies for new products.
• Provide regulatory input on other company
activities such as pharmacovigilance, medical affairs, risk management, company
brochures, and due diligence.
Education and Experience
• Extensive experience working in EU
• Significant industry experience
• Relevant Scientific qualification
(post graduate would be highly desirable)
• Experience in Immunology, Celland Gene
therapy (ATMPs) and Oncology desirable.
• Regulatory experience with early-phase
new product development for biotechnology products.
• Well-rounded regulatory experience
(CMC, clinical, non-clinical) and understanding of ATMP CMC development issues
understanding of EMA and MHRA clinical and CMC product development regulations.
Exposure to unique requirements of EU national regulatory authorities helpful.
• Highly experienced MS Word , Adobe
Acrobat Pro, MS PowerPoint user. Experience with MS Excel and MS Project desirable.
• Excellent verbal and written communication
• Excellent interpersonal skills, with
an ability to interact successfully with numerous stakeholders, remote teams
and across disciplines and levels
• Meticulous, organised and able to
work to deadlines
• Self-motivated, able to work
independently and possess excellent decision making skills
• Ability to think creatively in order
to achieve regulatory solutions for optimal product development
• Professionally credible and
• Must be willing to work full-time at
London Cell Medica office with excursions throughout London area as necessary.
• Some European and US travel may be
required (approximately 10% of time)