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Senior Manager CMC

Employer
Hobson Prior
Location
England, London
Salary
GBP65000 - GBP70000 per annum
Start date
23 Jan 2023
Closing date
3 Feb 2023

View more

Discipline
Regulatory Affairs, CMC
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management
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Job Details

Hobson Prior are currently seeking for a Senior Manager CMC to join a fantastic pharmaceutical organisation on a permanent basis located in London. Our client is focused on providing the best possible treatments to protect the health and wellbeing of many.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

  • For this position, you will partake in the CMC process initiatives to assist with the generation of both internal international and local SOPs and guidance papers.
  • The ideal candidate will offer training and direction to the less experienced members of the EU CMC regulatory team.
  • Guide engagements with health authorities to agree CMC regulatory tactics and data needs to enable successful approval of designated products/projects.
  • Forecast when and how regulatory concerns may affect the organisation and meticulously and swiftly advise project teams and management appropriately.
  • Any other assigned duties.

Requirements:

  • Acquaintance with small molecule dosage forms, specifically sterile and oral tablet products, or experience with biological products would be ideal.
  • Familiarity with assisting with early and late phase clinical development plans, with previous involvement in IMPD preparing for clinical trial applications.
  • Know-how of eCTD needs and acquaintance with planning CMC documentation for new product EU MAAs, such as Module 3, Module 2 QOS, Module 1 Quality related administrative documents.
  • Former involvement in assisting with post-approval variations for CMC alterations.
  • Experience supporting post-approval variations for CMC changes.
  • Acquaintance with age-suitable paediatric formulation regulations and needs, as well as assisting with preparing the CMC sections for PIPs.
  • Able to prepare scientific advice briefing papers for CMC/Quality linked content and/or queries.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Find Us
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
GB
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