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This is a great opportunity to join a pharmaceutical group which is enjoying significant growth both in Ireland/UK and internationally. The group of companies are proud of its expanding business which includes market leading brands across OTC and Prescription medicines. This role will suit someone who is fast paced and looking to work in a dynamic environment. The company works with a trusted network of global partners to identify and introduce clinically proven products.
About the Role
This role will involve developing and implementing regulatory strategies to support product development and lifecycle management.
Responsibilities
* Develop and implement regulatory strategies to support product development and lifecycle management
* Manage a team of Regulatory Affairs Officers to ensure the Company’s products comply with all relevant regulations and standards
* Efficiently integrate all new portfolio acquisitions in multiple markets
* Lead projects on identifying any gaps in dossiers and devising plan to resolve these gaps
* Lead meetings with Regulatory Authorities
* Lead regulatory aspects of internationalising products and applying for reclassification of products
* Monitor and interpret regulatory trends and changes relevant to the industry and pro-actively keep the Company appraised of these
* Collaborate cross functionally with Quality and Commercial/Marketing teams to achieve Company objectives
Qualifications
* Minimum of 8-10 years previous experience will be needed
Required Skills
* Highly resilient and adaptable, able to work under pressure and within time constraints
* Drives results on a timely basis and sees things through to conclusion
* Strong knowledge of global regulatory frameworks
* Knowledge of MRP, DCP, CP
* Knowledge of medical devices highly desirable
* Excellent attention to detail and organisational skills
* Capable of working on own initiative and taking responsibility for course of action
* Flexible and fast paced
Pay range and compensation package
Equal Opportunity Statement
The company is committed to diversity and inclusivity.
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Seniority level
* Seniority level
Executive
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance and Manufacturing
* Industries
Pharmaceutical Manufacturing and Medical Equipment Manufacturing
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Senior Regulatory Affairs Specialist - Pharma
Regulatory Affairs Manager - Pharmaceuticals
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