Senior Manager Regulatory Affairs
- Employer
- Hobson Prior
- Location
- Amsterdam, North Holland, Netherlands
- Salary
- EUR60000 - EUR70000 per annum
- Start date
- 3 Feb 2023
- Closing date
- 3 Mar 2023
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Senior Management
Job Details
Hobson Prior are looking for a Senior Manager Regulatory Affairs to join a brilliant pharmaceutical establishment on a permanent basis located in Amsterdam. Our client is focused on providing the best remedies to protect both the health and wellbeing of others.
Please note that to be considered for this role you must have the right to work in this location.
Key Responsibilities:
- For this role, you will guide the interactions with health authorities to approve CMC methods and data needs to enable successful agreement on allocated products/projects.
- Offer training and leadership to less experienced members of the EU CMC regulatory team.
- Forecast both when and how regulatory concerns may affect the business and conscientiously and quickly advise project teams and management accordingly.
- To assist in the production of internal international and local SOPs and guidance papers, you will partake in the CMC process initiatives.
- Any other assigned duties.
Requirements:
- Must be an EU citizen or currently reside in Amsterdam.
- Acquaintance with small molecule dosage forms, ideally sterile and oral tablet projects, as well as with biological products which would be beneficial.
- Familiarity with assisting in early and late phase clinical development projects with prior involvement in IMPD planning for clinical trial applications.
- Know-how of eCTD needs and familiarity with planning of CMC documentation for new product EU MAAs such as Module 3, Module 2 QOS, Module 1 Quality associated administrative documents.
- Past involvement in assisting post-approval variations for CMC changes.
- Know-how of EMA and ICH regulatory CMC/Quality regulations applicable across the product lifecycle.
- Former involvement with age-suitable paediatric formulation regulations and needs, as well as assist in planning CMC sectors for PIPs.
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.
- Website
- http://www.hobsonprior.com/
- Telephone
- 01892 612 612
- Location
-
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom
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