CMC Senior Manager Regulatory Affairs
- Employer
- i-Pharm Consulting
- Location
- Dublin, Dún Laoghaire, Republic of Ireland
- Salary
- Negotiable
- Start date
- 23 Nov 2020
- Closing date
- 7 Dec 2020
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Management
Job Details
Senior Manager Regulatory Affairs - CMC
16 month contract with Biopharmaceutical company
€50 per hour
Must be already based in Ireland and able to commute to Dun Laoghaire once COVID restrictions lift
To facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.
Job Summary
The RA CMC Site Team is responsible for input to the development and implementation of CMC regulatory strategies and activities for products manufactured at or planned for the specific site.
The CMC site team interfaces with the site (R&D and operations authors) coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity.
The CMC site team are members of CMC product teams.
The CMC Site team is also responsible for coordination of site-specific change control regulatory assessments with input from the CMC Product teams and the CMC Region representative.
The CMC site team is the key RA CMC representative on product deviation investigation teams.
Key Activities
Responsible for the strategy and execution of the site-specific aspects of the preparation of CMC investigational product amendments and post-market supplements, organization and preparation CMC sections of IND annual reports and annual reports of minor changes for specific products; acts as key RA CMC representative on product deviation investigation teams, participates in site change control teams
Knowledge and Skills
MUST HAVE - CMC- specific regulatory knowledge & experience
Education & Experience (Basic) Doctorate degree
OR
Master's degree and 3 years of directly related experience
OR
Bachelor's degree and 5 years of directly related experience
OR
Associate's degree and10 years of directly related experience
OR
High school diploma / GED and 12 years of directly related experience
Education & Experience (Preferred)
Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry
Regulatory CMC experience
Company
i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.
We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.
Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world.
With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.
For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them.
As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.
We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.
- Website
- http://www.i-pharmconsulting.com/
- Telephone
- +44 (0) 20 3189 2299
- Location
-
52 Bedford Row
London
England
WC1R 4LR
United Kingdom
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