CK Group are recruiting for a CMC Regulatory Affairs Manager to join a
company in the Pharmaceutical industry at their site based in Dun
Laoghaire on a **Apply on the website** month contract.
*The Company:*
Our client is one of the worlds leading manufacturers of biosimilar
and biopharmaceutical products used in the treatment of a wide range
of human healthcare conditions from cancer to arthritis. This company
are a strong believer in helping patients by developing new treatments
and taking them to market via their global network of specialist
aseptic manufacturing, packaging and distribution sites.
*The Location:*
This role is located on a state of the art manufacturing facility
based in Dun Laoghaire and is a quick **Apply on the website** minute
drive away from the centre of Dublin, or **Apply on the website**
minutes drive from Dublin Airport. The site is easily commutable from
Kildare or Wicklow by car and there is a good public transport network
if you would prefer to live within Dublin itself. Dun Laoghaire is a
vibrant cultural hub innt(s) procurement, preparation and
coordination. You will also serve as liaison with other functional
teams at the site in support of registration activities and generation
and management of required documentation.
*Key Responsibilities:*
* 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
* 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.
*Your Background:*
* CMC- specific regulatory knowledge & experience
* 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 or to apply for this CMC Regulatory Affairs
Associate position, please contact Natasha on , quoting job ref
**Apply on the website**.
It is essential that applicants hold entitlement to work in Ireland. Location: D?n Laoghaire
CK Group are recruiting for a CMC Regulatory Affairs Manager to join a
company in the Pharmaceutical industry at their site based in Dun
Laoghaire on a **Apply on the website** month contract.
*The Company:*
Our client is one of the worlds leading manufacturers of biosimilar
and biopharmaceutical products used in the treatment of a wide range
of human healthcare conditions from cancer to arthritis. This company
are a strong believer in helping patients by developing new treatments
and taking them to market via their global network of specialist
aseptic manufacturing, packaging and distribution sites.
*The Location:*
This role is located on a state of the art manufacturing facility
based in Dun Laoghaire and is a quick **Apply on the website** minute
drive away from the centre of Dublin, or **Apply on the website**
minutes drive from Dublin Airport. The site is easily commutable from
Kildare or Wicklow by car and there is a good public transport network
if you would prefer to live within Dublin itself. Dun Laoghaire is a
vibrant cultural hub innt(s) procurement, preparation and
coordination. You will also serve as liaison with other functional
teams at the site in support of registration activities and generation
and management of required documentation.
*Key Responsibilities:*
* 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
* 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.
*Your Background:*
* CMC- specific regulatory knowledge & experience
* 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 or to apply for this CMC Regulatory Affairs
Associate position, please contact Natasha on , quoting job ref
**Apply on the website**.
It is essential that applicants hold entitlement to work in Ireland.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
