We are presently recruiting Pharmaceutical Regulatory Affairs specialist / Manager for our Kerry based clients. Duties include working on US dossier applications to FDA for NADA, EU applications, and dossier creation to secure further marketing authorisations internationally. The role will include pharmaceutical, safety and efficacy sections of dossier preparation. The role will also assist in post marketing activities such as renewals and variations.
Knowledge and prior experience in regulatory affairs dossier filing for Injectable sterile products is a distinct advantage. Additionally, experience in the Pharmaceutical industry in QC will be beneficial. As a minimum the applicant should have an honours science degree with some experience in the pharmaceutical industry.
What we are looking for:
- We are looking for an individual with Regulatory Affairs experience within the Pharmaceutical industry. you will ensure that requirements of the industry and regulatory bodies are fulfilled.
- You will be Responsible for the communications and interactions with the Competent Authorities in relation to the Authorized Representative duties.
- You will contribute to Regulatory Affairs activities across the company, ensuring successful and timely approval of all relevant regulatory submissions, ensure global regulatory compliance and to ensure delivery on corporate goals.
- Provide guidance on regulatory development activities and new product evaluations.
- To ensure successful collaboration between regulatory, clinical and quality assurance to support the business
What I need to be a Senior Regulatory Affairs Manager?
- Experience in Pharma regulatory affairs including time spent in Industry and/or in a regulatory agency/notified body with demonstrated understanding of and ability to interpret regulations and guidelines governing
- In-depth understanding of the required Pharmaceutical regulatory guidelines and standards
- Possess the requisite expertise regarding the regulatory requirements for the Pharmaceutical Sector in the European Union demonstrated by a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned in, engineering or another relevant scientific discipline,
- Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
- Experience with Regulatory Authorities.
- Ability to work independently and complete multiple assignments on time Knowledge and/or experience in International registrations and clinical studies is a plus.
Salary is open to negotiation depending on qualifications and experiences. For further information, please email me directly.
Red Chair Recruitment, Recruitment House, 91 New Street, Killarney, Co. Kerry, Ireland
Tel: +353 (0) 64 66 22 007
Mob: +353 (0)86 468 1212