Senior Regulatory Affairs Associate – FSP

This is a fully remote position, open to applicants in Australia.

📋 Description

• Oversee the management of the post-authorization lifecycle.

• Prepare, organize, and coordinate documentation specific to local requirements to ensure regulatory compliance.

• Provide support for health authority inspections as necessary.

• Handle variations, renewals, PSURs, label updates, and CMC alterations.

• Manage interactions with health authorities and respond to inquiries.

• Utilize both internal document management systems and external platforms.

• Coordinate assessments of the impact for technical changes that influence marketing authorization.

• Collaborate with medical, marketing, manufacturing teams, and other non-regulatory partners.

• Keep abreast of local regulatory requirements and guidelines, relaying this information to GRA and team members.

• Participate in regulatory meetings, sharing insights and best practices.

• Function independently as well as part of a team to deliver project services.

• Prioritize tasks and complete designated project activities in accordance with project guidelines.

• Deliver high-quality work that meets the expectations of project leads and clients.

• Potentially lead smaller projects or workstreams within larger projects.

• Plan and establish projects, coordinating forecasting, financial entries, invoicing, reporting, training compliance, risk escalation, and closure activities.

• Act as the primary point of contact for clients, ensuring accurate project reporting.

• Recognize opportunities for changes in scope and additional business.

• Provide consulting services within your area of expertise.

• Identify project and client needs, proposing solutions in collaboration with senior staff.

• Assist with presentations, project scoping calls, and the preparation of proposals.

• Build industry relationships and communicate potential business leads.

• Complete timesheets, expense reports, maintain CVs, ensure training compliance, archive deliverables, and participate in internal initiatives.

• Stay active in relevant industry or scientific/technical associations and define personal development activities.

⛳️ Requirements

• Extensive knowledge and practical experience in Australia and New Zealand.

• Prior experience in the industry supporting Global and/or local Regulatory teams.

• Thorough understanding of regional and global regulatory requirements, guidelines, and processes.

• Advanced expertise in managing local health authority interactions.

• Strong knowledge of post-authorization lifecycle maintenance processes, including variations, renewals, and PSURs.

• Experience in managing interactions with health authorities and responding to inquiries.

• Familiarity with using document management tools and external platforms.

• Ability to prepare, organize, and coordinate local-specific documentation, including Module 1.

• Capability to maintain national systems in accordance with local legislation.

• Skill in managing or coordinating impact assessments for technical changes affecting marketing authorization.

• Ability to collaborate with medical, marketing, manufacturing, and other non-regulatory stakeholders.

• Knowledge of local regulatory requirements and guidelines.

• Proficient in project management principles.

• Client-focused work approach.

• Results-oriented mindset.

• Strong teamwork and collaboration abilities.

• Excellent written and verbal communication skills, with interpersonal and intercultural proficiency.

• Strong critical thinking and problem-solving capabilities.

• Proficient in the local language and possess extensive working knowledge of English.

• Over 4–5+ years of experience in an industry-related environment in Australia, including New Zealand.

• Minimum of a Bachelor's Degree in a Scientific or Technical Discipline.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Opportunities for professional development and continuous learning.

• Flexible work arrangements to support work-life balance.

• Comprehensive health and wellness programs.

• Access to industry events and networking opportunities.