Principal Consultant Regulatory Strategist

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Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

Principal Consultant Regulatory Strategist brings scientific depth and regulatory foresight to product and business strategy anticipating regulatory and policy trends, shaping development paths, and enabling commercial advantage. This role is defined by influence: partnering with the rest of the regulatory strategy team, CMC, clinical strategy, clinical operations, quality, legal and commercial leaders to design pathways to market and lifecycle value, not merely to follow them.
The Principal Consultant Regulatory Strategist is a senior scientific leader within the Regulatory Strategy team, reporting directly to the SVP Regulatory Strategy.
The Principal Consultant Regulatory Strategy will contribute to further strengthen and deepen Alira’s scientific and strategic regulatory capabilities by bringing advanced regulatory science expertise, analytical foresight, and cross-functional integration to complex development programs.
Working together with the SVP Regulatory Affairs, this role enhances the quality, rigor, and forward-looking dimension of regulatory strategy, supporting optimized development pathways, robust authority engagement preparation, and defensible scientific positioning.
This role complements and reinforces the existing regulatory leadership structure and contributes to elevating regulatory thinking as a competitive advantage for clients.

Job Description

As a senior scientific and strategic contributor, the Principal Consultant will:

• Provide high-level regulatory science expertise across product modalities and therapeutic area

• Contribute to the development and refinement of global regulatory strategies defined at SVP level

• Lead scientific preparation for high-impact authority interactions

• Strengthen internal regulatory foresight capabilities

• Mentor regulatory strategists

• Support commercial initiatives through scientific thought leadership

This is a client-facing role requiring strong scientific judgment and the ability to translate complex regulatory science into practical development recommendations.

KEY RESPONSIBILITIES

Strategic foresight

• Lead regulatory foresight (monitoring, horizon scanning and scenario planning) to identify emerging regulatory, policy and scientific trends and translate these into actionable recommendations for clients and internal teams.

Develop and lead global regulatory strategies for client drug development programs.

• Co-create integrated development strategies and regulatory roadmaps that align scientific design, clinical strategy, CMC and commercial when appropriate to support client’s objectives.

• Explore alternative pathways that optimize use of Agency tools, programs to enhance the development journey  and lifecycle value in particular for early development projects.

• Advise on benefit–risk trade-offs, evidence generation plans, and options for accelerated/alternative pathways.

• Proactively identify emerging regulatory trends and translate them into actionable recommendations for client’s programs.

• Anticipate regulatory risks and opportunities

Authority engagement

• As required lead and prepare teams and clients for high-impact authority interactions (scientific advice, pre-submission/Pre-IND meetings). Act as senior representative with health authorities and third-party evaluators where needed.

• Support clients in shaping meeting strategy, messaging and follow-through to maximize strategic outcomes.

Technical stewardship & delivery

• Oversee preparation, critical review and approval of high-quality regulatory science deliverables and dossier components for a range of submissions and authorizations across jurisdictions and product types.

• Ensure rigorous submission standards, high quality scientific argumentation and defensible regulatory positions.

Leadership, people & capability building

• Support the SVP Regulatory Strategy Mentoring and developing a multi-disciplinary team of regulatory strategists . Develop and implement practices, tools, templates and standards to deliver consistent, high-value advice.

• Embed regulatory strategy into product teams and coach non-regulatory leaders to use regulatory thinking as a business advantage.

• Lead the development and responsible integration of AI-enabled capabilities within regulatory strategy, including identification of use cases, governance considerations, and scientific validation standards, to enhance analytical rigor, efficiency, and competitive differentiation.

Commercial & thought leadership

• Proactively contribute to new client acquisition by identifying business opportunities, leveraging network relationships, and supporting strategic account expansion initiatives.

• Play an active role in business development by shaping proposals, participating in client pitches, and converting regulatory strategy insight into commercially compelling solutions.

• Accountable for the financial performance and compliance of assigned projects, including scope management, budget oversight, margin optimization, and alignment with contractual commitments.

• Contribute to revenue growth by expanding existing client portfolios through strategic advisory services, cross-selling opportunities, and long-term engagement development.

• Produce high-level thought leadership that strengthens Alira’s market positioning and supports commercial growth.

KEY RELATIONSHIPS

• Internal: SVP, Regulatory and the entire Regulatory team; Clinical, CMC, Quality, Market Access, Commercial, Legal; Project Leads; Business Development.

• External: FDA, EMA, EU National agencies MHRA, and other regulators; industry consortia; technical experts and academic collaborators; clients and their leadership teams.

SUCCESS CRITERIA

• Achievement of annual financial objectives.

• Client satisfaction scores

• Client retention and repeat business rate.

• Recommendation to new opportunities by existing clients

• Include wording for cross-selling inside Alira Health

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES

• Advanced degree in Life Sciences, Pharmacy, Medicine, Regulatory Science or related discipline (PharmD/PhD/MD preferred).

• 15 years progressive experience in regulatory strategy or regulatory science across industry and/or consulting, including leadership/people-management responsibilities.

• Demonstrable experience leading regulatory strategy across multiple product modalities and jurisdictions and a track record of successful authority interactions.

• Exceptional scientific judgement and the ability to translate technical science to business impact.

• Strong influencing, negotiation and stakeholder management skills — comfortable with C-suite engagement.

• Commercial mindset and experience contributing to proposals and client development.

• Strategic application of AI-enabled and digital tools to enhance regulatory efficiency, submission quality, and lifecycle value while ensuring full compliance with global regulatory standards.

• Excellent written and verbal communication; additional languages an asset.

Languages

Education

Contract Type

Regular