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About the Role
Provide strategic regulatory and product development advice to internal and external stakeholders, and manage client projects. Support development programs from early development through clinical development and marketing application activities across multiple regulatory jurisdictions.
Responsibilities
- Develop and provide strategic regulatory advice to clients across the product development lifecycle, including development of regional and global regulatory strategies.
- Lead or contribute to regulatory strategy integrating APAC, U.S., EU, and other applicable regional requirements, identifying differences, risks, dependencies, and practical development options.
- Prepare, review, and critically assess high-quality regulatory documents and submissions, including clinical trial applications, INDs, Regulatory Authority meeting packages, responses to Regulatory Authority questions, and other development and lifecycle submissions.
- Lead and participate in interactions with Regulatory Authorities, including development of meeting strategy, preparation of briefing materials and questions, meeting participation, and assessment and implementation of regulatory feedback.
- Independently manage client projects, including scope, timelines, deliverables, budget awareness, resource coordination, client expectations, and proactive communication of project status and risks.
- Provide strong client-facing leadership, including communicating complex regulatory issues clearly, providing practical recommendations, setting expectations, and escalating significant risks or issues early.
- Critically review regulatory, scientific, and development documentation to identify inconsistencies, gaps, and risks and ensure alignment with agreed regulatory strategy and prior Regulatory Authority feedback.
- Work effectively across clinical, CMC, nonclinical, medical writing, statistics, and other disciplines to develop integrated regulatory strategies and ensure high-quality, timely delivery of client work.
- Support business development activities through regulatory input to proposals, client discussions, scope development, and identification of opportunities to provide additional value to existing and prospective clients.
- Build strong collaborative relationships with clients, Regulatory Authorities, internal stakeholders, and cross-functional project teams.
Requirements
- Minimum 6 years of relevant regulatory affairs experience for Senior Consultant level.
- Demonstrated ability to independently manage regulatory activities and client projects, with senior support available for particularly complex or novel global strategy decisions for Senior Consultant level.
- Minimum 12 years of relevant regulatory affairs experience for Principal Consultant level.
- Demonstrated ability to independently develop and lead complex global regulatory strategy, manage high-complexity client programs, and provide senior regulatory leadership with limited oversight for Principal Consultant level.
- Strong APAC regulatory expertise, with demonstrated ability to independently develop and lead regional regulatory strategy.
- Strong knowledge of U.S. regulatory requirements, including experience leading or contributing to IND development, Regulatory Authority meeting strategy, lifecycle management, and other U.S. submissions.
- Demonstrated experience contributing to or leading global regulatory strategy across multiple regions.
- Excellent regulatory writing and critical review skills, with the ability to identify strategic, scientific, and regulatory inconsistencies and ensure documents align with Regulatory Authority feedback and agreed regulatory strategy.
- Strong client-facing communication, judgment, and problem-solving skills.
- Demonstrated ability to manage multiple high-priority projects and deliverables in a consulting or similarly fast-paced environment.
- Strong cross-functional leadership, ownership, and execution, including effective engagement with clinical, CMC, nonclinical, medical writing, statistics, and other subject matter experts.
- Degree in a relevant scientific, clinical, pharmacy, or life sciences discipline, or equivalent relevant experience.
Skills
- Strategic regulatory advice
- Product development advice
- Client project management
- Regulatory strategy development
- Regulatory document preparation and review
- Interaction with Regulatory Authorities
- Risk identification and mitigation
- Client leadership
- Cross-functional collaboration
- Communication
- Problem-solving
- APAC regulatory expertise
- U.S. regulatory requirements
- Global regulatory strategy
- Regulatory writing
- Critical review
- Client-facing communication
- Project management
- Cross-functional leadership
Location
- Australia
Work Type
- Permanent
- Full-time
Experience Level
- Senior Consultant
- Principal Consultant
Education Level
- Degree in a relevant scientific, clinical, pharmacy, or life sciences discipline, or equivalent relevant experience.
Benefits
- Flexible benefits framework (NovoLife)
About the Company
- Novotech is a global full-service clinical Contract Research Organization (CRO).
- Ambition meets opportunity at Novotech.
- Globally recognized leader in clinical research and scientific advisory services.
- Award-winning workplace culture that values ambition, innovation, and growth.
- Named Employer of Choice, Great Place to Work and Employer of Choice for Gender Equality (EOCGE).
- Committed to fostering an environment that reflects the life-changing work we do.
- Expanded global footprint with 30+ offices across Asia-Pacific, the United States, and Europe.
- Unites professionals from diverse backgrounds and disciplines to advance therapies that improve patient outcomes worldwide.
- Employees are at the heart of our success.
- Offers trust, flexibility, and autonomy through programs like NovoLife, our flexible benefits framework.
- Empowers team members to create an effective work-life balance that delivers professional satisfaction and maximum results for clients.
- Access to mentorship opportunities, professional development programs, and a dynamic community.
- Platform for driven individuals to achieve personal growth while shaping the future of healthcare.
- Team that values contributions and supports ambition to make a global impact.
- Advanced therapeutic and regulatory expertise.
- Ability to execute across markets.
- Client-centric service model.
- Trusted, long-term partner and an accelerated path to bring life-changing advances to market.
- Opportunity to develop careers by joining a diverse and supportive global organization with a collaborative culture.
- Working with clients on the cutting-edge of life sciences.
- Work alongside empowered teams with a shared commitment to success.
- Strategic vs transactional mindset.
- Ability to gain insights and make proactive decisions quickly.
- Culture that fosters partnership and collaboration, where every voice is heard and valued.
- Ongoing support from senior stakeholders and leadership team.