This innovator pharmaceutical organisation's number one priority will always be the patients they serve. With a pipeline that features late stage development programs and a strong commercial portfolio of products, this leader is driving the development of products for rare diseases with significant unmet medical needs. Through the organisation's portfolio of approved products and promising pipeline focused on hepatology and nephrology, this business strives to help people achieve the best possible outcomes today and tomorrow. As the business continues to expand out their Irish operation, an important requirement has arisen in the business for a Senior Director Regulatory Affairs Europe to head up the organisations RA strategy in the EU.
- Define, plan and execute the European regulatory strategy for products including maintaining and extending product registrations in EU markets.
- Design EU regulatory strategies in close collaboration with Global Regulatory Lead to obtain, maintain and extend product registrations in Europe.
- Provide regional regulatory expertise and work in collaboration with the Regulatory Lead to organise and provide support to meetings with European Health Authorities.
- Provide global regulatory strategic insight and regulatory procedural expertise in line with applicable directives and regulatory guidelines.
- Collaborate closely with internal and external Regulatory stakeholders (Strategy/Development, CMC, Labeling, and Operations) to ensure all aspects of regulatory strategies are coordinated and considered.
- Lead the oversight of accurate and timely compilation to ensure submission of regulatory documentation.
- Lead the organisation's European Regulatory Affairs function including providing direction, guidance, and mentorship to direct report(s).
- Represent Regulatory Affairs in organisational European matters and operations. Lead cross-functional submission teams to ensure creation and submission of qualitative regulatory documents (MAA, Briefing documents, Variations, ODD, PIP, responses to questions and other relevant regulatory filings) within defined timelines as per company objectives.
- Manage and partner with the assigned CRO and functional stakeholders to ensure the timely submission, approval and compliance of all CTA applications conducted in the European region, as applicable.
- Establish and foster strong working relationships with appropriate contacts at relevant regulatory agencies, especially the European Medicines Agency and regulatory agencies in the EU member states to ensure regulatory applications are approved in a timely manner.
- Remain knowledgeable about current regulations and guidance, interpret and notify appropriate personnel of any changes, updates or revisions.
- Communicate and collaborate with the partner organisations to ensure all parties are informed of activities directly affecting their market.
- Provide EU regulatory expertise to ensure necessary knowledge is transferred throughout the Regulatory team and internal stakeholders.
- Ensure applicable regulatory requirements are considered and appropriately incorporated into all programs, to adhere to compliance with appropriate regulations, guidelines and post market commitments.
- Support new Business Development initiatives including due diligence and regulatory technical assessments as needed.
- Bachelor's Degree in a scientific and/or Life Sciences discipline. Advanced degree MD, PhD or PharmD preferred. Equivalent combination of education and applicable job experience may be considered.
- Minimum of 12 years in drug/biologics development in the pharmaceutical and biotechnology industry or Government Health Agency, with at least 6 years of experience in a regulatory leadership role.
- Demonstrated track record of successful approvals and extensive regulatory agency liaison experience is essential.
- Strong expertise and knowledge of the drug development process, MAA and launch requirements is required.
- Strong understanding of European Union laws and procedures relating to drug market authorisations.
To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.