Clinical Regulatory Scientist Associate – Cork, Ireland

Requirement: EU Passport or Irish Stamp 4

Salary up to €68k + 5%annual bonus

Primary Responsibilities:

Regulatory and Scientific Expertise

1. Develop, Update and Execute US and Canada Registration Strategy

• Assist the Regulatory Scientist in the development of regulatory strategy by leveraging scientific, drug/device clinical development and knowledge from FDA/Health Canada meetings and regulatory trends. Integrate information from the external environment, product-specific regulator advice, and other public information (i.e. Advisory Committees) to develop robust, innovative regulatory strategies.
• Review and summarize, information regarding regulator expectations by utilizing agency feedback received by the company and knowledge of competitor labelling.
• Monitor upcoming and recent approvals of competitive programs
• Communicate and share key information to enable seamless execution of US/Canada regulatory strategy

2. Provide input to clinical programs to support market differentiation needs

• Communicate the regulatory options and impact on proposed product development plans, seeking Regulatory Scientist and management alignment.
• Leverage innovative regulatory strategies with accompanying required data to accelerate asset development while enabling market differentiation.

3. Develop and Update US and CA labelling, including prescribing information, patient labelling, and device labelling (IFU) for new products and indications

• Support strategic development of US/CA labelling documents for initial submission, line extensions, key MOH-initiated changes, and key PMR-related updates, and respond to agency labelling questions in collaboration with Regulatory Scientist. Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content to influence commercially viable labelling.
• Confirm, challenge, influence, and communicate strategic discussions based on industry precedent and new developments.

4. Support the development of the strategy for submission and amendments for IND, IDE, NDA/BLA, NDS, PMA/510(k), and de novo

• Determine and communicate submission and approval requirements and regulator expectations
• Assist Regulatory Scientists to generate regulatory documents for submissions. Ensure the regulatory documents contain appropriate data/information based on regulator expectations and are written to articulate the company’s scientific position.
• Anticipate, resolve, and communicate key technical, operational, and strategic issues that may impact the MDU function or the development team.
• Propose innovative solutions to regulatory and labelling issues to meet the business objectives while maintaining compliance with applicable regulations and internal quality systems.

5. Liaison with late lifecycle/legacy product team

• Provide high-quality, timely and decisive regulatory advice, in collaboration with the Regulatory Scientist, that enables business partners to make well-informed decisions on the development of drugs, diagnostics, devices, and product lifecycle planning and business development
• Communicate regulatory risks, potential impact and mitigation plans with development team leadership and regulatory management
• Cultivate relationships with development teams.

6. Support relationship and interaction strategy with US and Canadian regulatory authorities

• Build, maintain, and leverage relationships with team members, and partner companies as appropriate.
• Execute high-quality communications with FDA, Health Canada and internal customers to articulate and ensure understanding of the regulatory strategy in partnership with Regulatory Scientists.
• Support communications to the regulator, development teams, and GRA, MDU, Research, and BU leadership.

Lead/Influence/Partner

• Exemplify Team behaviours: Include, Innovate, Accelerate, and Deliver in internal and external interactions
• Model the innovation and leadership behaviours and regulatory excellence attributes as described in Global Regulatory Affairs white papers.
• Participate in forums that share regulatory information across GRA components and other company teams and business partners
• Constructively challenge teams to reach the best solutions to issues
• Create and lead in an environment that encourages open discussions on issues to achieve a robust outcome on business decisions

Desired Qualification Requirements:

• Bachelor’s degree in science or health sciences discipline
• Preferred industry-related experience in regulatory affairs and/or drug development experience for 2 years
• Knowledge of FDA and Health Canada procedures and practices across Review Divisions and awareness of evolving regulatory reform initiatives desirable
• Demonstrated deep knowledge of the drug development process, company regulatory/business strategies and plans required
• Demonstrated ability to assess and manage risk in a highly regulated environment
• Demonstrated strong written, spoken and presentation communication
• Demonstrated negotiation and influence skills
• Demonstrated attention to detail
• Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles