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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.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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