What are the responsibilities and job description for the Associate Director Regulatory Affairs (Clinical / Publishing / Compliance) position at Talent Groups?
- Advanced degree in life sciences, public health, or related field (PhD, PharmD, or equivalent strongly preferred).
- 8-10 years of industry experience in regulatory affairs, clinical research, medical writing, or related areas, with 5 years in clinical trial disclosure and transparency.
- Demonstrated expertise in global disclosure regulations (FDA/ClinicalTrials.gov, EU CTR, EudraCT, EMA Policy 0070, Health Canada PRCI, Japan PMDA, WHO).
- Proven track record of building and leading global teams and/or major transparency initiatives.
- Strong understanding of clinical development, regulatory submissions, and data privacy principles.
- Exceptional leadership, communication, and collaboration skills.
Preferred Skills
- Prior experience representing an organization in external working groups (PhRMA, BIO, TransCelerate, CTTI, etc.).
- Expertise in data anonymization, redaction technologies, and patient-level data-sharing platforms.
- Experience establishing or maturing a global transparency governance framework.
- Ability to influence and drive alignment across executive leadership and global stakeholders.