Regulatory Affairs Specialist

About PSC Biotech Ltd

Who we are?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

Take your Career to a new Level

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry.We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Overview:

This role represents an excellent opportunity to be part of the commercial regulatory affairs environment of the Animal Health division of a world leading human and animals medicines manufacturer 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.

Responsibilities:

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 mmarketing 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 and GDP responsibilities may be part of this role

Requirements

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 a commercial regulatory environment would be considered an advantage and is preferred, but not essential.

- Ability to assess quality of technical data in relation to regulatory requirements

- Ability to assemble and present data

- 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 ability to work to challenging deadlines and managing conflicting priorities.

- Team player, ability to work well with other