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Job Details
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Senior, CMC Regulatory Affairs Manager (Gene Therapy)

Business Type: Pharmaceutical Company
Job Type: Regulatory Affairs
Job Level: Experienced (non manager)
Position: Full Time
Location: Italy
Reference: 70008
Closing Date: 02/12/21
Job Details:

One of the biggest research institute in Italy is looking for a Senior Manager in CMC Regulatory Affairs to enter their academic and research foundatin.

The Role

As a Senior Manager in CMC Regulatory Affairs, you will provide expert knowledge
on exciting area of ex-vivo and in-vivo gene therapy within the Translational
Project Management & Regulatory Affairs Group which is part of our Research &
Development Division.

The Unit is growing and there are excellent opportunities for professional
development and enhancing your skills. With a variety of new gene addition and
gene editing projects, we are looking to enhance the knowledge within our team with
the addition of this hire. Activities encompass translational early and late stage drug
development, with insight into marketing registration & access and product

We are seeking an individual with experience in technical development, testing and
manufacturing of gene therapy medicinal products (GTMP). In particular, with cell
and gene therapies in-depth experience in one of the following areas: analytical
testing and characterization, control strategies, cell culture, vector production,
process design/development, starting/raw materials quality criteria definition, stem
cells/linfo T-based GT development. Knowledge of quality & compliance in the GT
field is a plus.
This resource will provides a range of regulatory writing services with supervision of
senior team members to a high quality and on time delivery. You''re expected to work
independently and on more complex projects.


* Provide strategic regulatory guidance to SR-TIGET colleagues, and
Telethon/OSR on gene therapy medicinal products (GTMP) drug
development, registration, and post-market. Provides regulatory advice
and making reasoned decisions on CMC regulatory issues for which
there may not be clear/specific regulatory guidance.
* Understand of scientific principles and regulatory CMC requirements
relevant to global drug development (manufacturing, characterization,
CQA, comparability, stability, etc) and post-market support and apply to
the integrated project development plan.
* Actively anticipate and develop initial or alternative EU/US regulatory
strategies, consulting with other resources within the organization as
* Lead and/or participate in the review of CDMO selection, quotations and
service agreement negotiations, quality agreement definition for projects
commissioned to third specialized parties (i.e, starting materials, key
reagents, DS/DP, etc).
* Effectively manage the preparation of CMC regulatory submission
documents (IMPD/IND, other relevant briefing packages) including
National GMO authorizations.
* Facilitate CMC IMPD/IND submission, approvals and amendments
through leading communications and negotiations with regulatory
agencies and project teams as necessary, directly and indirectly.
* Provide the project teams with strategic advice in response to regulatory
agencie''s queries, based on regulatory experience and area of expertise.
* Provide the project teams with advice in comparability exercises as
required depending on the strategy.
* Enthusiastically monitors for new regulatory evolutions, contribute to
guideline revisions and train/cascade internally key findings/updates.
The ideal candidate has attention to detail, positive team relationships with
colleagues, good communication, organizational and analytical skills.
* Bachelors degree in a relevant discipline, preferably in a life sciences, or
other healthcare field.
* Advanced degree (MSc., PhD., M.D., Pharm.D., MBA) in the biological,
medical, chemical or engineering field may be beneficial.
* 5+ years pharmaceutical gene therapy Regulatory CMC experience in the
global environment (e.g. Europe and US) including experience as an RA
CMC product lead, or equivalent industry experience (e.g.,
Pharmaceutical Development, Analytical Development, Production,
Quality Assurance) - international experience preferred.
* Experience with pharmaceutical development of gene therapies products,
analytical characterization, process scale-up, stability and/or GT
regulatory registration of products is a pre-requisite.
* Demonstrable experience in a regulatory CMC role or in the delivery of
regulatory CMC strategy and documentation during drug development
and/or product maintenance.
* Experience supporting business development activities management.
* Demonstrates leadership, problem-solving ability, flexibility and values
* Demonstrated ability to work well within a matrix structure in a complex
* Exercises good judgement in timely elevating and communicating actual
or potential issues to line management and presents solutions to those
* Excellent written and oral communication skills required.
* Active participation in Agency/Industry groups/forums preferred.
* Certification in regulatory affairs (RAC) or post-secondary institution

As usual, if interested I''d suggest you to send an email to with your CV.

NonStop Consulting Limited Posted by:: NonStop Consulting Limited (View all our vacancies)
Unless otherwise stated, if applying for a job, you must ensure that you are already authorised to work in the country in which the job is based
Posted: 25/11/2021 | NPJ Ref: 291660
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