Job Description

About the Company

We are a multinational biopharmaceutical innovator specialising in advanced biologics, precision oncology, rare disease therapeutics, and next-generation cell & gene therapies. Our pipeline spans Phase I through global commercialisation across the U.S., EMA, MHRA, PMDA, and emerging regulatory markets.

With multiple breakthrough therapy designations and accelerated approval programs underway, our organisation operates at the forefront of scientific innovation and regulatory complexity. We partner with global health authorities to bring transformative treatments to patients in high-need therapeutic areas.

As regulatory frameworks evolve around gene editing, biologics manufacturing, AI-assisted clinical trials, and expedited pathways, we are seeking a Regulatory Affairs Consultant to provide strategic guidance across development, submission, and lifecycle management initiatives.

This is not a documentation-only role. This is a strategic regulatory leadership position influencing global product approvals and market access strategy.

Job Function

The Regulatory Affairs Consultant will provide expert-level regulatory strategy across clinical development programs, global submission planning, health authority interactions, and lifecycle compliance management.

This role requires deep expertise in biologics and advanced therapy regulatory frameworks, as well as strong experience navigating complex, multi-region regulatory environments.

Essential Duties and Responsibilities

• Develop and execute global regulatory strategies for biologics and advanced therapy products

• Lead preparation and submission of INDs, BLAs, MAAs, CTAs, and accelerated approval filings

• Serve as primary regulatory liaison with FDA, EMA, and other global health authorities

• Provide strategic guidance on orphan drug designation, breakthrough therapy pathways, and priority review programs

• Oversee regulatory submission content strategy, including CMC, nonclinical, and clinical documentation

• Guide cross-functional teams in regulatory risk mitigation and compliance planning

• Conduct regulatory intelligence assessments and competitive landscape analyses

• Support labelling negotiations and product lifecycle management strategies

• Provide oversight on post-approval commitments and pharmacovigilance coordination

• Review manufacturing and quality documentation for compliance with global GMP standards

• Contribute to regulatory due diligence during business development and licensing initiatives

Strategic Support

• Advise executive leadership on regulatory timelines and risk exposure

• Shape global market entry strategies aligned with reimbursement and access considerations

• Support clinical development strategy with regulatory pathway optimisation

• Assist in health authority meeting preparation and briefing documentation

• Provide regulatory guidance during mergers, acquisitions, and asset licensing

• Contribute to the global expansion strategy in emerging regulatory jurisdictions

Job Qualifications and Requirements

• 8–15+ years of progressive regulatory affairs experience in biopharmaceuticals

• Demonstrated expertise in biologics, gene therapy, or advanced therapeutic medicinal products (ATMPs)

• Proven track record of successful global regulatory submissions and approvals

• In-depth knowledge of FDA, EMA, ICH guidelines, and international regulatory standards

• Experience interacting directly with global health authorities

• Strong understanding of CMC requirements for biologics manufacturing

• Advanced degree in Life Sciences, Pharmacy, Regulatory Science, or related field (PhD, PharmD, MS preferred)

• RAC certification preferred

Personal Capabilities and Qualifications

• Strategic thinker with deep regulatory foresight

• Strong analytical and risk-assessment capabilities

• close attention to scientific and regulatory detail

• Executive-level communication skills

• Ability to manage cross-functional global teams

• Strong ethical standards and commitment to patient safety

• Adaptability in rapidly evolving regulatory landscapes

Working Conditions

• Hybrid working model with global collaboration

• 15–25% travel for regulatory authority meetings and global program reviews

• High-accountability environment tied to submission milestones

• Interaction with executive leadership and scientific advisory boards

• Fast-paced, innovation-driven biotech setting

Compensation & Benefits

Total Compensation Package: $130,000 – $228,000 USD

Compensation Includes:

• Competitive base salary within stated range

• Performance-based annual bonus

• Equity participation (where applicable)

• Comprehensive health, dental, and vision coverage

• Retirement savings plan with employer contribution

• Professional certification and conference sponsorship

• Generous PTO and global holiday schedule

• Wellness and employee assistance programs

Why Join Us

• Contribute to life-changing therapies in oncology and rare diseases

• Influence global regulatory strategy at an advanced therapeutics leader

• Engage directly with global health authorities

• Work alongside world-class scientists and clinical experts

• Competitive compensation aligned with expertise and impact

• Opportunity to shape regulatory pathways in emerging biotechnologies