Job Details: Senior Regulatory Affairs Officer


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Senior Regulatory Affairs Officer
JOB DESCRIPTION

We are currently recruiting for a Senior Regulatory Affairs Officer to
join a rapidly growing Global Regulatory Affairs team located in
Dublin. Your role will be to prepare, contribute to and manage MAAs
and Lifecycle activities for current and actively growing range of
pharmaceutical products, therapeutic indications and international
markets.

RESPONSIBILITIES

Acts as responsible Regulatory Team member for assigned regulatory
projects
* Preparation of submissions including Marketing Authorization
Transfer, CMC variation filling, initial MAA filling, labelling
updates, renewals, CMC authoring and or updates as required.
* Prepares and/or reviews regulatory documentation for DCP, MRP and
National applications in line with assigned timelines.
* Actively participates and employs effective communication
practices with internal customers (CMC, Supply Chain, Quality, Legal,
Clinical, Pharmacovigilance, Regional Regulatory Managers, Regional
Heads).
* Understands the Scope of Work, timelines and deliverables for a
given project.
* Prepare status reports and metrics for assigned projects
* Perform assigned work according to current best regulatory
practice and in compliance with current legislation and regulatory
guidelines.
* Any other duties as assigned by your Manager
* MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Degree in Pharmacy or life science-related degree plus at least 2
year?s relevant human pharmaceutical experience with focus on filing
and lifecycle maintenance of marketed products in Europe and/or
emerging markets
* **Apply on the website** years regulatory experience, focusing on
lifecycle maintenance of marketed products in Europe and/or emerging
markets (e.g. variations, renewals, new Marketing Authorisation
Applications (MAAs) submissions)
* Preparation of relevant CTD (Common Technical Dossier) documents
to support submissions, in collaboration with
Technical/CMC/Clinical/Labelling experts
* Experience of EU DCP and MRP MAAs
* Experience of emerging markets / international RoW markets and
regulatory filings
* Quality control review of technical/ regulatory documents
* Understanding of Regulatory strategy and determination of
documentation requirements, timelines, budgets and filing options
* Compliance with SOPs Change controls and regulatory best practices
* Pharmaceutical artwork review and sign-off
* Project management experience - an advantage
* Experience of Women?s and/or Men?s healthcare ? an advantage

For full details and confidential discussion please contact Linda ?or
email your cv to (Please contact us using the "Apply for this Job
Posting" box below)
JOB DESCRIPTION

We are currently recruiting for a Senior Regulatory Affairs Officer to
join a rapidly growing Global Regulatory Affairs team located in
Dublin. Your role will be to prepare, contribute to and manage MAAs
and Lifecycle activities for current and actively growing range of
pharmaceutical products, therapeutic indications and international
markets.

RESPONSIBILITIES

Acts as responsible Regulatory Team member for assigned regulatory
projects
* Preparation of submissions including Marketing Authorization
Transfer, CMC variation filling, initial MAA filling, labelling
updates, renewals, CMC authoring and or updates as required.
* Prepares and/or reviews regulatory documentation for DCP, MRP and
National applications in line with assigned timelines.
* Actively participates and employs effective communication
practices with internal customers (CMC, Supply Chain, Quality, Legal,
Clinical, Pharmacovigilance, Regional Regulatory Managers, Regional
Heads).
* Understands the Scope of Work, timelines and deliverables for a
given project.
* Prepare status reports and metrics for assigned projects
* Perform assigned work according to current best regulatory
practice and in compliance with current legislation and regulatory
guidelines.
* Any other duties as assigned by your Manager
* MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Degree in Pharmacy or life science-related degree plus at least 2
year?s relevant human pharmaceutical experience with focus on filing
and lifecycle maintenance of marketed products in Europe and/or
emerging markets
* **Apply on the website** years regulatory experience, focusing on
lifecycle maintenance of marketed products in Europe and/or emerging
markets (e.g. variations, renewals, new Marketing Authorisation
Applications (MAAs) submissions)
* Preparation of relevant CTD (Common Technical Dossier) documents
to support submissions, in collaboration with
Technical/CMC/Clinical/Labelling experts
* Experience of EU DCP and MRP MAAs
* Experience of emerging markets / international RoW markets and
regulatory filings
* Quality control review of technical/ regulatory documents
* Understanding of Regulatory strategy and determination of
documentation requirements, timelines, budgets and filing options
* Compliance with SOPs Change controls and regulatory best practices
* Pharmaceutical artwork review and sign-off
* Project management experience - an advantage
* Experience of Women?s and/or Men?s healthcare ? an advantage

For full details and confidential discussion please contact Linda ?or
email your cv to (Please contact us using the "Apply for this Job
Posting" box below)


We need : English (Good)

Type: Permanent
Payment:
Category: Others

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