Director, Global Regulatory Strategist -Allergy/Cardiovascular Portfolio

Role Summary

Director, Global Regulatory Strategist – Allergy/Cardiovascular Portfolio is responsible for developing and leading global and regional regulatory strategies and implementation plans for allergy and cardiovascular projects/products, including novel therapies, enhancements, and post-approval changes. The role provides regulatory input to clinical development, ensures aligned regulatory positions across assigned projects, and leads interactions with Health Authorities to obtain Marketing Authorizations.

Responsibilities

• Developing Global/Regional regulatory strategies and implementation plans for Allergy and Cardiovascular projects/products; optimize delivery time and probability of a successful outcome.
• Providing regulatory input to clinical development programs, risk/benefit assessments, and target label development.
• Ensuring an aligned regulatory position is reached and communicated for key issues; champion and execute regulatory positions on time to quality standards.
• Serving on the Product Labelling Team to contribute to CCDS development and local label maintenance as appropriate.
• Cultivating relationships across stakeholders to drive aligned regulatory approaches and policies.
• Monitoring regulatory plans, communicating progress to Senior Management, and mitigating risks from data, objectives, or external impacts.
• Directing documentation to meet regulatory requirements for Marketing Authorizations; authoring dossier sections as applicable.
• Developing and maintaining relationships with Health Authority contacts; organizing/leading meetings with regulatory agencies; ensuring quality expectations for submissions and interactions.
• Collaborating with Regulatory team members to ensure consistent processes, systems, and quality standards.
• Understanding evolving global/regional regulations and guiding impact assessment and influence through Health Authority engagement and partnerships.
• Supporting regulatory due diligence for business development opportunities.
• Providing input to and adherence to departmental budget.

Qualifications

• Required: Minimum of a Bachelor's degree (or equivalent). An advanced scientific degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or a business qualification (DMS, MBA) may be advantageous but is not essential.
• Required: Minimum of 8 years in regulatory, and at least 5 years of global regulatory experience (US/EU); a combination of experience and/or education will be considered.
• Required: Global Regulatory Affairs strategy experience with hands-on authoring (initial registrations or post-approval variations) – minimum 5+ years.
• Required: Deep knowledge of development & commercial activities to assess clinical, scientific, and regulatory data; focus on Allergy and Cardiovascular products.
• Required: Extensive experience shaping project strategy, reducing regulatory burden, and improving regulatory flexibility across global markets; ability to execute complex projects across drug development and manufacturing lifecycles.
• Required: Advanced understanding of current and emerging regulatory requirements and expectations; experience negotiating with regulatory authorities.
• Required: Ability to partner with Regulatory, Clinical, Safety, Medical, Commercial, R&D, Legal, and senior stakeholders to achieve objectives.
• Preferred: Allergy and Cardiovascular therapeutic areas expertise.
• Required: Advanced written and oral communication skills.
• Required: Computer literacy with Microsoft Office and Documentum-based applications.
• Required: 5+ years of managing projects and matrixed teams or prior people management experience.
• Required: Ability to engage with regulatory authorities to respond to requests, alone or with Regulatory Affairs personnel.
• Required: Demonstrated commitment to scientific and regulatory integrity; proven ability to collaborate with multiple lines and stakeholders; proven track record of delivering on time, cost, and quality.
• Required: Strategic thinking with the ability to translate strategies into actionable plans; capable of leading with minimal supervision.

Skills

• Advanced written and oral communications
• Stakeholder engagement and negotiation
• Strategic regulatory planning and leadership
• Regulatory submission planning and authoring
• Health Authority liaison and meeting preparation
• Cross-functional collaboration and project management

Education

• Bachelor’s degree required; advanced scientific degree or business qualification preferred

Additional Requirements

• 5+ years of people management or matrixed team leadership experience
• Experience with regulatory authority interactions and responses
• Ability to travel as needed
• Proficiency in English (reading, writing, speaking)