ABOUT REGASK

RegASK is a global regulatory intelligence platform powered by AI, helping businesses stay ahead of evolving regulations across markets. Our platform delivers timely, structured updates tailored to client needs in sectors like food, feed, cosmetics, and others

QUALIFICATIONS

• Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field; advanced degree (MSc, PharmD, PhD) preferred.
• Over 10 years of regulatory affairs experience in pharmaceutical, biotech, and/or medtech industries, with strong knowledge of both drug and device regulatory frameworks.
• Expertise in U.S. FDA regulations (including drug and device pathways), with preferred experience in EU (EMA) and Australian (TGA) regulatory systems.
• Proven experience in regulatory due diligence, gap assessments, and developing go-to-market strategies for biotech and medtech products.
• Good understanding of clinical development, including trial design, ethical approvals, and regulatory submissions (IND/CTA).
• In-depth knowledge of CMC compliance and manufacturing scale-up readiness in biotech context.
• Proficient in Quality Management Systems (QMS) principles and application.
• Ability to review high-level intellectual property portfolios, assess regulatory exclusivity, and identify associated risks.
• Excellent communication and client-facing skills, with the ability to manage multiple projects independently and collaborate effectively across teams.Strong analytical, organizational, and writing skills, capable of translating complex regulatory information into clear, actionable reports.

ROLE OVERVIEW

We are seeking a highly experienced and self-driven Senior Regulatory Affairs Project Manager – Life Sciences to lead and deliver regulatory consulting projects for pharmaceutical clients. This is a hands-on, individual contributor role responsible for managing end-to-end project execution, including regulatory due diligence, gap assessments, and market-entry strategy development .
The ideal candidate will be client-facing , capable of independently managing project lifecycles from initiation through final delivery while ensuring client satisfaction. In addition, this role may support the Sales team by helping scope client requests and assist the Marketing team in reviewing or developing regulatory-focused content.
The successful candidate must have deep expertise in U.S. pharmaceutical regulatory requirements , with preferred experience in EU and Australian regulatory frameworks . You will be responsible for producing high-quality regulatory reports and coordinating with internal teams and regional experts to ensure accurate and relevant outcomes.
This position requires a strategic thinker with excellent communication and project management skills, along with the ability to work autonomously in a fast-paced, client-driven environment.

KEY RESPONSIBILITIES

• Lead end-to-end regulatory consulting projects for Biotech/Medtech/pharmaceutical clients, including regulatory due diligence, gap analysis, and market-entry strategy development.
• Serve as the primary client contact, managing communications, timelines, and expectations throughout the project lifecycle to ensure high levels of client satisfaction.
• Independently prepare and deliver high-quality regulatory reports/support, tailored to client-specific needs and aligned with applicable regional requirements.
• Collaborate with internal stakeholders (e.g., Sales, pre-sales, customer success, etc.) and engage regulatory subject matter experts when needed.
• Interpret and apply U.S. pharmaceutical regulatory requirements (FDA), with the ability to navigate and compare global frameworks, particularly in the EU and Australia.
• Support the Sales team in scoping prospective client projects by providing regulatory insight and defining deliverables, timelines, and required expertise.
• Contribute to Marketing efforts by reviewing or developing regulatory content for white papers, blogs, webinars, or promotional materials.
• Ensure project milestones and deliverables are met on time, within scope, and to the highest quality standards.
• Maintain up-to-date knowledge of relevant regulatory trends, guidances, and changes across priority markets.Drive continuous improvement in project delivery processes, client engagement, and internal collaboration.