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
Team Leadership:
- 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.
Key Competencies:
- 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.
