Job Details: Regulatory Affairs Manager CMC


JobsIreland
Jervis Street
Dublin 1
Regulatory Affairs Manager CMC
Orion Group Sciences are looking for a Regulatory Affairs Manager CMC
for our Multinational Pharmaceutical Client based in the South Dublin
area on an initial **Apply on the website**-month contract with the
potential to extend.

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.

Organization CMC, Device Regulatory, Pediatrics and Biosimilars

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

CMC- specific regulatory knowledge & experienceEducation & Experience
(Preferred)

Experience in manufacture, testing (QC/QA or clinical), or
distribution in Pharmaceutical/Biotech industry

Regulatory CMC experience

Doctorate degree

OR Master&#**Apply on the website**;s degree and 3 years of directly
related experience

OR Bachelor&#**Apply on the website**;s degree and 5 years of directly
related experience

OR Associate&#**Apply on the website**;s degree and**Apply on the
website** years of directly related experience

OR High school diploma / GED and**Apply on the website** years of
directly related experience

For more information on this role, call Denise Cagney on (0) (phone
number removed) or email (url removed) for a completely confidential
chat about this role and other opportunities using the reference
number: (phone number removed)

Our role in supporting diversity and inclusion

As an international workforce business, we are committed to sourcing
personnel that reflects the diversity and values of our client base
but also that of Orion Group. We welcome the wide range of experiences
and viewpoints that potential workers bring to our business and our
clients, including those based on nationality, gender, culture,
educational and professional backgrounds, race, ethnicity, sexual
orientation, gender identity and expression, disability, and age
differences, job classification and religion. In our inclusive
workplace, regardless of your employment status as staff or contract,
everyone is assured the right of equitable, fair and respectful
treatment

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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