Health authority interactions jobs

Director, APAC, Regulatory Affairs, Immunology

6084-Janssen Research & Development Legal Entity · Posted Nov 12, 2026

Open

Beijing, China
Full-time · Manager
10+ years

Apply with Referso

Director, APAC, Regulatory Affairs, Immunology

6084-Janssen Research & Development Legal Entity · Posted Nov 12, 2026

Open

Beijing, China
Full-time · Manager
10+ years

Apply with Referso

Director, APAC, Regulatory Affairs, Hematology

Johnson & Johnson Innovative Medicine · Posted Nov 12, 2026

Open

Chiyoda, Tokyo, Japan
On-site
Full-time · Manager
8+ years

Apply with RefersoAI Apply on careers page

Lead regional regulatory strategy and operations for APAC, overseeing regulatory submissions, interactions with health authorities, and management of regulatory staff across multiple AP countries.

Responsibilities

Define and implement regional regulatory strategy for assigned products
Lead and provide regulatory strategic input for assigned therapeutic areas
Coordinate regulatory submissions and ensure compliance with local regulations
Manage interactions with local operating companies and health authorities
Oversee regulatory staff and provide coaching and development

Requirements

Bachelor's degree in pharmacy or life-science or health-related discipline
Master's degree or PharmD with 8+ years experience
PhD with 6+ years experience
Nice to have: Business Writing
Nice to have: Collaboration

Skills

Regulatory strategy Pharmaceutical industry knowledge Local laws and regulations in AP region Drug development and registration Health authority interactions

Senior Director, Regulatory Affairs - Early Development/Business Development

Insmed Incorporated · Posted Sep 11, 2026

Open

Remote, United States
Remote
Full-time · Director
$222K–$303K per year
10+ years

Apply with RefersoAI Apply on careers page

Provide strategic and operational regulatory leadership to support both early-stage drug development and business development programs.

Compensation

Pay Range: $222,000.00-303,000.00 Annual

Responsibilities

Strategic evaluation of regulatory risks and opportunities for external assets
Assessing likelihood of technical and regulatory success
Contributing to the development and execution of global regulatory strategies for internal pipeline programs
Represent the regulatory affairs department on due diligence assessments for external assets
Critically assess completeness and adequacy of nonclinical, clinical, and CMC data packages

Requirements

PhD
PharmD
MS
Nice to have: Regulatory due diligence
Nice to have: Business development

Skills

Regulatory Affairs Global regulatory frameworks Drug development process Regulatory submissions Health authority interactions

Executive Director & Site Quality Head

Denali Therapeutics · Posted Sep 9, 2026

Open

Salt Lake City, Utah, United States
15+ years

Apply with RefersoAI Apply on careers page

Lead and manage the QA and QC teams at Denali’s Utah manufacturing site, ensuring compliance, inspection readiness, and continuous improvement of quality systems.

Compensation

Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits.

Responsibilities

Oversee GMP/GLP Quality operations in Utah
Accountable for overall compliance and inspection readiness
Develop and maintain site culture and long-term strategy
Build, supervise, develop, promote, hire and train QA and QC teams
Represent Quality on the Utah Site Leadership Team and Denali Quality Leadership Team

Requirements

Bachelor's in a scientific discipline
Master's preferred
Professional certification in quality, compliance and/or regulatory
Nice to have: Large molecule experience
Nice to have: Commercialization experience

Skills

GMP GLP QC QA CAPA

Regulatory Affairs Director

AstraZeneca · Posted Nov 5, 2026

Open

Barcelona, Catalonia, Spain
Hybrid
Full-time · Manager
5+ years

Apply with RefersoAI Apply on careers page

Lead global and regional regulatory strategy, manage regulatory submissions, interact with health authorities, and oversee regulatory milestones for assigned products.

Responsibilities

Lead development and implementation of regional or global regulatory strategy
Lead cross-functional teams in major health authority interactions
Prepare regulatory strategy documents and target product labeling
Negotiate with health authorities
Update senior management on project risks and mitigation

Requirements

Advanced degree in a science related field
Nice to have: Benefit/risk profile
Nice to have: Dose selection
Nice to have: Statistical design
Nice to have: Experience in small molecules & biologics

Skills

Regulatory drug development Health authority interactions Phase 3 design Labeling negotiations Strategic thinking Strategic influencing

Director, APAC, Regulatory Affairs, Immunology

Director, APAC, Regulatory Affairs, Immunology

Responsibilities

Requirements

Skills

Director, APAC, Regulatory Affairs, Hematology

Responsibilities

Requirements

Skills

Senior Director, Regulatory Affairs - Early Development/Business Development

Compensation

Responsibilities

Requirements

Skills

Executive Director & Site Quality Head

Compensation

Responsibilities

Requirements

Skills

Regulatory Affairs Director

Responsibilities

Requirements

Skills

Benefits

Benefits