Job description

About PSC Biotech

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.

Description:

Regulatory Compliance Specialist

Position Summary:

This position is responsible for supporting tasks and projects related to management of Regulatory Compliance and new product submissions at ****.

These activities include QA/Compliance support for worldwide submissions of new drug applications and post approval changes, change control support, manufacturing support and manufacturing license maintenance.

• Point of Contact to request, source and provide relevant regulatory documentation (e.g. SOPs, Technical Reports, Deviations, Quality Agreements) to support miscellaneous regulatory requests such as paper-based inspections (e.g. Taiwan, Japan etc).

• In collaboration with Regulatory Management, ensure maintenance of the commercial and clinical manufacturers licenses.

• Notarization and legalization management.

• In collaboration with Regulatory Management, works on completing country specific registration, re-registration, accreditation requests.

• Co-ordinate SMEs for reviews of new product and post approval variations submissions to ensure that the *** sections are accurate and consistent across all products.

• Works with the Regulatory Manager to ensure Regulatory Playbook is maintained and updated in line with current product workflows.

• In collaboration with Regulatory Management, coordinating the Change Summaries for submission in the product Annual Reports, as required.

• Familiarization with license content and license sections in eCTD viewer and work with both the QPs and Regulatory Manager to ensure transparency of information and escalation information is shared.

• Regulatory support for routine manufacturing / Quality operations.

• Knowledgeable on regulatory systems such as ERIS, RIACS, GRAIL, RIMDocs, eCTD, etc.

Requirements

Key Competencies Required:

• Collaboration and team work

• Problem solving and attention to detail

• Customer focused

• Clear communication skills

• Adaptable and flexible

More Details:

• Days - hybrid (3 days onsite).

• Ideally looking for 2-3 years experience of QA experience in Pharma.

• Experience or educational qualification in a Regularity based field would be an advantage.

• No graduates !!!

​#LI-BR1

Job Type: Full-time

Salary: €28,454.22-€42,000.00 per year

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Cork, County Cork: reliably commute or plan to relocate before starting work (required)

Reference ID: 12327

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