Job Details: Regulatory Affairs Specialist

Jervis Street
Dublin 1
Regulatory Affairs Specialist

* Perform Regulatory Affairs activities ensuring compliance with
applicable regulations and requirements (FDA, HC, MHRA, HPRA),
including but not limited to
* Oversee and contribute to the preparation of regulatory
submissions and registrations
* Manage submission timelines, monitor approval status and
communicate change status to concerned parties in a timely manner
* Prepare, review and/or approval of regulatory change controls,
risk assessments
* Respond to Competent Authorities’ queries and deficiencies in a
timely manner
* Maintain a good understanding of existing and emerging
pharmaceutical regulations and provide regulatory direction and
* Monitor and interpret new and existing regulations and
guidance’s to evaluate the impact on the NorthStar business
* Liaise effectively with internal departments and external
suppliers to support the timely introduction of new products to market
* Support activities for the UK marketReview and approval of
NorthStar artwork for UK market, including colour selection and
approval of digital proofsLifecycle management of supplier Safety Data
Exchange AgreementsOperate medical communications line in accordance
with supplier SDEAsMaintain appropriate and current records


The above statements describe the general nature and level of work
being performed in this job. They are not intended to be an exhaustive
list of all duties. Additional responsibilities may be assigned, as
required, by management. 



Educated to degree level or higher in Chemistry, Microbiology or other
scientific discipline

5+ years FDA regulated pharmaceutical experience; **Apply on the
website**+ years regulatory affairs experience

* Thorough understanding of regulatory and compliance guidelines
within pharmaceutical manufacturing
* An understanding of relevant directives, standards, policies and
guidelines and the ability to implement appropriately
* Excellent interpersonal skills, self-motivation and sense of
urgency to complete assignments on time
* Excellent communication skills with ability to communicate at all
levels within the organization
* Ability to work independently and make decisions based on
judgement and integrity
* Proven analytical and problem solving skills and the ability to
transfer findings into report and presentation formats
* Ability to work effectively with others to accomplish goals in a
challenging environment
* Excellent organisational and time management skills
* Understanding of customs and beliefs of other groups or cultures
* Familiarity with concepts of Regulatory Approval process for
generic pharmaceutical products an advantage


We need : English (Good)

Type: Permanent
Category: Others

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