Senior Regulatory Affairs Strategist

Pinewood Healthcare; Ballymacarbry; On-site; EUR 70,000 - 90,000; Full time

Job summary

Pinewood Healthcare in Ireland is seeking a Regulatory Affairs Specialist to join our team at the Ballymacarbry site. The role focuses on renewals, variations and marketing authorisation submissions, with guidance from the Regulatory Affairs Manager.

You will provide regulatory support to manufacturing, ensure compliance, manage EVMPD/eMC processes and interact with regulatory authorities as needed. A degree in life sciences and TOPRA familiarity are desirable.

Qualifications

• Educated to at least degree level in a life science with significant experience in regulatory affairs.
• Membership of The Organization for Professionals in Regulatory Affairs (TOPRA) is preferable.
• Ability to organise own workload with a minimum of supervision.
• Basic appreciation of all aspects of the pharmaceutical industry.
• Experience with information technology desirable.
• Exceptional eye for detail required.
• Ability to present the Company's interests to regulatory bodies and negotiate effectively.
• Excellent written and verbal communication and interpersonal skills.
• Strong problem-solver and resourceful.

Responsibilities

• Collate, prepare and progress renewals, variations and marketing authorisation applications.
• Provide regulatory support to manufacturing to ensure regulatory compliance of products manufactured on site.
• Supervise the administration of the eMC website and ensure EVMPD compliance.
• Coordinate and prepare submission packages for regulatory authorities; monitor dossiers for clarity and responses.
• Respond to questions raised by regulatory authorities with information from relevant departments.
• Represent regulatory affairs at internal and external meetings as directed.
• Operational use of the Pharmaceutical Quality System to maintain integrity and support continuous improvement.

Skills

Regulatory affairs experience

Attention to detail

Negotiation

Communication skills

IT experience

Independent thinker

Education

Degree in life science

Job description

Pinewood Healthcare in Ireland is seeking a Regulatory Affairs Specialist to join our team at the Ballymacarbry site. The role focuses on renewals, variations and marketing authorisation submissions, with guidance from the Regulatory Affairs Manager.

You will provide regulatory support to manufacturing, ensure compliance, manage EVMPD/eMC processes and interact with regulatory authorities as needed. A degree in life sciences and TOPRA familiarity are desirable.