Regulatory Affairs Senior Specialist Job Description
As a key member of our regulatory affairs team, the Regulatory Affairs Senior Specialist will play a critical role in ensuring the company's compliance with all relevant health authority regulations and guidelines.
Job Responsibilities:
* Preparation and maintenance of high-quality dossiers (marketing authorisation applications/responding to health authority questions/post-approval submissions)
* Submission of CPP/manufacturing authorisation requests to HPRA/MHRA
* Review of data intended for submission and advising on any deficiencies or issues
* Ensuring timely submissions for all quality/safety-related changes for assigned projects
* Preparation and submission of translated texts to EU/Non-EU countries
* Updating databases and systems for all products (in-line with current SOPs)
* Liaising with third parties (where required) to establish effective communication and relationships in order to progress regulatory activities
* Liaising closely with business development, product launch, artwork, supply chain, and quality colleagues to ensure alignment in all initiatives
* Advising management of the status and progress of assigned projects, identifying potential problems or delays, and possible solutions as they occur
* Maintaining an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent authorities) and using this information to optimise departmental procedures and processes and to ensure Health Authority requirements and Regulatory Compliance are maintained
Key Skills and Qualifications:
We are looking for a candidate with a strong background in regulatory affairs, possessing excellent organisation skills, time management skills, and attention to detail. The ideal candidate will have:
* A Master's/Bachelor's degree or equivalent in Science/Technology/Pharmacy
* A minimum of 7 years' experience in regulatory capable of understanding health authority expectations for pharmaceuticals for EU/US/ROW regions
* Excellent critical thinking and problem-solving abilities
* Strong interpersonal and communication skills
* Experience in dealing with multiple stakeholders, both internal and external
What We Offer:
As a valued member of our team, you will have the opportunity to work with a dynamic and innovative company that is dedicated to developing and manufacturing patient-friendly pharmaceutical products. You will be part of a collaborative and supportive environment that fosters growth and development.