Regulatory Affairs Specialist - II
- Employer
- i-Pharm Consulting
- Location
- Dublin, Republic of Ireland, Dublin South
- Salary
- Up to GBP0.00 per annum
- Start date
- 21 Sep 2022
- Closing date
- 5 Oct 2022
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Management
Job Details
Regulatory Affairs
11 month contract
€40.15 per hour + 25 days annual leave and 10 day's public holiday
Leading Animal Health company
Description
This role represents an excellent opportunity to be part of the commercial regulatory affairs environment of our client's Animal Health organisation in Ireland. The primary objective of the role is to obtain and maintain veterinary medicinal product marketing authorisations in line with business and legal requirements in the Republic of Ireland.
This role is responsible for undertaking a variety of regulatory activities for a range of veterinary medicinal products including:
- Submission of new marketing authorisation applications, management and maintenance of existing marketing authorisations via submission of applications to vary marketing authorisations, submission of renewal applications, and other submissions to ensure regulatory and market compliance in Ireland.
- Generation, maintenance and control of product literature approvals (labelling text and packaging artwork) in line with regulatory requirements and company labelling artwork approval systems.
- Coordination of communication with global regulatory and European licensing team colleagues to ensure appropriate documentation is supplied to the regulatory authorities within appropriate timelines.
- Communication of marketing authorisation change approvals to ensure efficient and compliant change implementation.
- Provide internal advice and expertise on all regulatory matters in support of support of business objectives.
- Supporting and maintaining local company regulatory and quality compliance systems.
- Some GDPR responsibilities are part of this role
Qualifications, Skills & Experience Required
- A degree in a discipline that is relevant such as a life-sciences degree or suitable alternative such as veterinary science or pharmacy or related subject matter.
- Experience in veterinary regulatory affairs.
- Experience in a commercial regulatory environment would be considered an advantage and is preferred, but not essential.
- Excellent computer skills are essential. Sound working knowledge of Microsoft Office 2010 applications and ability to work in/with a variety of customised applications.
- Excellent verbal and written communication skills, with the ability to interact with a wide range of people both internal and external, including regulatory authorities.
- Meticulous approach and attention to detail.
- The ablity to work to challenging deadlines and managing conflicting priorities.
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.
- Website
- http://www.i-pharmconsulting.com/
- Telephone
- +44 (0) 20 3189 2299
- Location
-
52 Bedford Row
London
England
WC1R 4LR
United Kingdom
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