Head of Regulatory Affairs

T-pro; Dublin; On-site; EUR 70,000 - 100,000; Full time

Job summary

A leading pharmaceutical company is seeking a Regulatory Affairs Manager to oversee regulatory compliance for their operations in Ireland. The successful candidate will lead a team, manage regulatory submissions, and ensure adherence to European regulatory standards, contributing to the company's mission of delivering quality pharmaceuticals.

Qualifications

• Minimum 7 years' experience in Regulatory Affairs.
• Experience in CMC regulatory activities.
• Strong understanding of GMP and GDP standards.

Responsibilities

• Lead and manage the Regulatory Affairs team.
• Oversee compliance with regulatory requirements.
• Coordinate the preparation of Marketing Authorization Applications.

Skills

Leadership

Project Management

Regulatory Knowledge

Quality Assurance

Education

Degree in Pharmacy or Life Sciences

Postgraduate in Regulatory Affairs

Job description

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Position Overview:

• We are seeking a skilled and experienced Regulatory Affairs Manager to lead our Regulatory Affairs function in Ireland. This role will be responsible for overseeing day-to-day regulatory activities, providing regulatory guidance to the team and ensuring compliance with applicable requirements for our pharmaceutical products.
• This position requires a combination of supervision responsibilities and hands-on involvement in regulatory operations, with a particular focus on GMP compliance, regulatory quality assurance, and regulatory CMC-related activities to support our manufacturing site.

Required Qualifications and Experience:

• A degree in Pharmacy, Life Sciences, or a related discipline. Postgraduate qualifications in Regulatory Affairs or Pharmaceutical Sciences are advantageous.
• Minimum of 7 years of progressive experience in Regulatory Affairs within the pharmaceutical industry, including management responsibility.
• Experience in CMC regulatory activities and documentation.
• Experience in Regulatory Quality Assurance is highly desirable.
• In-depth knowledge of European regulatory requirements (CP, DCP, MRP, national procedures) and familiarity with ROW markets is a plus.
• Proven experience in people leadership, project management, and cross-functional collaboration.
• Strong understanding of GMP, GDP, and pharmaceutical quality systems.
• Experience supporting organizational changes and process improvements.

Key Responsibilities

• Lead, develop, and manage the local Regulatory Affairs team to ensure high performance, collaboration, and compliance with training and development plans by providing guidance, support, and decision-making assistance.
• Ensure that team members have clear objectives, up-to-date job descriptions, and adequate resources to meet operational goals.
• Support team development through mentoring and knowledge sharing.
• Manage departmental budgets and resource allocation to support current and future regulatory requirements.

Regulatory Operations:

• Plan, coordinate, oversee, and actively support the preparation and submission of new Marketing Authorisation Applications (MAAs), variations, renewals, and other post-approval activities in the territories assigned, according to the global strategies.
• Handle complex regulatory submissions and provide hands-on support for critical projects.
• Review and write /contribute to CMC sections for regulatory submissions using validated document management systems.
• Lead the preparation and review of CMC documentation and adaptation of CMC parts for various territories based on local requirements.
• Ensure timely and compliant submissions to EU or other international regulatory agencies, using validated publishing tools.
• Track and evaluate the impact of the CMC changes across different markets.

GMP and Regulatory Quality Assurance:

• Maintain regulatory compliance between registered MA dossiers and manufacturing/site operations.
• Oversee compliance with regulatory requirements for manufacturing, packaging, testing, and distribution activities.
• Review and approve from a regulatory point of view, when necessary, GMP documentation, product artworks, and other regulated documents.
• Support Quality Assurance during inspections and audits.
• Ensure alignment between regulatory commitments and site operations.

Authority Interactions:

• Serve as the primary contact for interactions between HBP with regulatory authorities (e.g. HPRA, EMA), including attending meetings, managing correspondence, and preparing responses to queries.

Cross-functional Collaboration:

• Collaborate closely with Corporate Global Regulatory Affairs to align local activities with global regulatory strategy.
• Work closely with Quality, Supply Chain, R&D, and Commercial teams and provide regulatory guidance and expertise to internal stakeholders.
• Provide regulatory support to internal and external stakeholders, including provision of documentation, submission guidance, and communication of regulatory changes.

Compliance Management:

• Monitor regulatory changes affecting manufacturing operations and implement updates to processes and procedures as necessary.
• Support organizational changes and process improvements from a regulatory perspective
• Prepare, review, and maintain department SOPs.
• Participate in internal initiatives and continuous improvement projects aligned with company objectives.
• Strategic and analytical thinking with a proactive approach to regulatory challenges.
• Hands-on approach to regulatory activities with attention to detail.
• Excellent communication skills, both written and verbal, with experience interacting with health authorities.
• Demonstrated ability to manage multiple projects and deadlines in a dynamic environment.
• High attention to detail and commitment to regulatory excellence and compliance.
• Good communication skills with experience in cross-functional collaboration.
• Problem-solving skills with a focus on practical solutions.
• Adaptability to changing priorities and requirements.
• Strong interpersonal and leadership skills, with a focus on team development and mentoring.

The Company:

The Helsinn Group has a commercial presence in over 90 countries and has proven expertise in areas such as Oncology Supportive Care, and Pain and Inflammation medicines.

This job is based at the Group's finished pharmaceutical manufacturing plant, Helsinn Birex Pharmaceuticals Ltd (FDA and IMB approved) which has operated at Damastown Industrial Estate, Mulhuddart, since 1997. HBP develops, manufactures and packages finished dose forms in tablet, granulate, capsule and gel formats. In addition, the company carries out final packaging of special dosage forms such as sterile forms and softgel which are produced by its worldwide network of CMOs.

For more information, visit our website: www.helsinn.com

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Pharmaceutical Manufacturing

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