Senior Regulatory Affairs Executive

Pinewood Healthcare; Ballymacarbry; On-site; EUR 60,000 - 90,000; Full time

Job summary

Pinewood Healthcare is seeking a Regulatory Affairs professional to lead regulatory submissions and ensure compliance across two sites in Ireland. You will collate renewals, variations and marketing authorisation applications while guiding manufacturing on regulatory obligations.

The role requires a degree in life sciences and proven regulatory experience, with TOPRA membership preferred. Excellent communication, attention to detail and the ability to work independently are essential in a

Qualifications

• Educated to degree level in a life science with significant regulatory affairs experience.
• Membership of TOPRA is preferable.
• Ability to organise own workload with minimal supervision.
• Good understanding of pharmaceutical regulatory processes and LIFE SCIENCE work.
• Excellent written and verbal communication skills.

Responsibilities

• Collate, prepare and progress renewals, variations and MAAs.
• Provide regulatory support to manufacturing for compliance of on-site products.
• Supervise administration of eMC website and EVMPD compliance.
• Coordinate submissions for regulatory agencies and respond to authorities.

Skills

Regulatory expertise

Attention to detail

Negotiation skills

Communication skills

Independent thinker

Education

Degree in life sciences

Job description

Pinewood Healthcare is a leading developer, manufacturer and marketer of healthcare products, currently employing over 300 people across two sites in Tipperary and Dublin. Originally established in 1976 to serve the renal care market in Ireland, Pinewood evolved over the years under indigenous Irish ownership until its sale in 2006 to the Wockhardt Group, an Indian global pharmaceutical and biotechnology company headquartered in Mumbai, India. Wockhardt employs over 7,000 people across 27 nationalities with a presence in the USA, UK, Ireland, Switzerland, France, Mexico, Russia and many other countries. It has manufacturing and research facilities in India, the USA and UK and a manufacturing facility in Ireland (Pinewood Healthcare).

Reporting to the Regulatory Affairs Manager, the role holder will:

• Collate, prepare and progress renewals, variations and marketing authorisation applications
• Provide regulatory support and guidance to manufacturing function to ensure regulatory compliance of products manufactured on site
• Supervise the administration of the eMC website and ensure EVMPD compliance.

Key Responsibilities (include but not limited to):

• Comply with SOPs and assist in their development and review
• Operate and propose improvements to internal systems
• Assist in the development of regulatory strategies
• Determine and communicate submission and approval requirements
• Assess the acceptability of documentation for submission
• Coordinate and prepare submission packages for regulatory agencies. Monitor the content of the dossiers ensuring the content is consistent, understandable and the results clearly expressed and that open questions have been dealt with
• Respond to questions raised by regulatory authorities by obtaining the relevant information from departments concerned
• Negotiate with regulatory authorities to achieve most favourable conditions for marketing authorisations or variations
• Commission and approve artwork for compliance prior to final signoff
• Draft Summary of Product Characteristics, Patient Information Leaflets and packaging
• Monitoring legislation and professional publications to maintain awareness of current regulatory practice and provide information on regulatory requirements to other departments and/or business units
• Respond to external/internal regulatory information requests
• Review GMP documentation for regulatory compliance, as directed
• Represent regulatory affairs at internal and external meetings as directed by the Regulatory Affairs Manager
• Operational use of and input to the Pharmaceutical Quality System will be achieved by maintaining the integrity of the Pharmaceutical Quality Systems, by engaging with and utilising the system in accordance with defined procedures and policies.

The job holder will, through supervisory guidance, contribute to improving the effectiveness of the Pharmaceutical Quality Systems by collection of metric data and other essential associated information which measures the system performance. In addition they will actively contribute to and participate in continuous improvements to products, processes and the Pharmaceutical Quality System with the aim of minimising patient, customer and business risks

Key Requirements:

• 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.
• He/she should have a basic appreciation of all aspects of the working of the pharmaceutical industry.
• Experience with information technology desirable.
• Exceptional eye for detail required.
• Requires the ability to present the Company's interests in a professional and authoritative manner and to conduct negotiations with regulatory bodies.
• Excellent written and verbal communication and interpersonal skills.
• Strong problem-solver.
• Resourceful.
• Independent, critical thinker with strong decision-making skills.
• Comfortable working in a busy, fast paced regulated healthcare