Global Regulatory Affairs Director – Immunology Submissions

Scorpion Therapeutics; Brisbane (CA); On-site; USD 220,000 - 254,000; Full time

Benefits offered by this job

Bonus

Equity

Job summary

Scorpion Therapeutics is seeking an senior Regulatory Affairs leader to shape global regulatory strategies for immunology and inflammation programs. You will work with Regulatory leadership, development teams, and CROs to deliver robust development plans and submissions.

You will represent Regulatory Affairs on cross-functional teams and drive interactions with global health authorities, including FDA/EMA, while guiding long-term strategic planning and risk mitigation.

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• 12+ years in Regulatory affairs strategy with immunology and inflammation experience.
• Strong knowledge of FDA/EMA and ICH guidelines.
• Hands-on experience planning clinical trials and marketing applications.
• Proven record supporting major filings and maintenance of clinical trial/marketing applications.
• Strong project management and communication skills; able to work independently or in teams.

Responsibilities

• Develop and implement global regulatory strategies for immunology/inflammation indications.
• Collaborate with Regulatory leadership, development teams, cross-functional partners, and CROs.
• Represent Regulatory Affairs on cross-functional development teams.
• Lead development and preparation of global submissions (IND, CTAs, NDAs, MAAs).
• Lead communication with Health Authorities (FDA, EMA), including meetings.
• Develop long-term regulatory strategy, including expedited development needs.
• Anticipate issues; guide risk mitigation and assess regulatory risk.
• Ensure adherence to regulations and SOPs; maintain submission plans.
• Define requirements for systems/tools for document management and regulatory information management.
• Track major submission deliverables; maintain submission plan templates.
• Participate in cross-functional initiatives; manage consultants/contractors as needed.

Skills

Regulatory strategy

FDA/EMA knowledge

ICH guidelines

Project management

MS Project

Smartsheet

Excel trackers

Communication skills

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Tools

MS Project

Smartsheet

Excel

Job description

Scorpion Therapeutics is seeking an senior Regulatory Affairs leader to shape global regulatory strategies for immunology and inflammation programs. You will work with Regulatory leadership, development teams, and CROs to deliver robust development plans and submissions.

You will represent Regulatory Affairs on cross-functional teams and drive interactions with global health authorities, including FDA/EMA, while guiding long-term strategic planning and risk mitigation.