Job Opportunity

Job Opportunity

Senior Director, Regulatory Affairs

Senior Director, Regulatory Affairs

United States Posted 2025-02-12

Senior Director, Regulatory Affairs

Job Summary

As the Senior Director of Regulatory Affairs, you will have the opportunity to learn and grow in a challenging environment. Report to and support the Head of Global Regulatory Affairs, you will navigate complex global challenges in a highly fluid regulatory environment, work closely with the Regulatory Affairs team in Biologics Development department (BioDev) to support the clients in regulatory submissions, especially in nonclinical (pharmacology, PK, and toxicology).

Responsibilities

Providing regulatory and scientific subject matter expertise to support the development of biologics and providing regulatory input for nonclinical development activities.
Writing, coordinating the preparation of, and critically reviewing nonclinical content for documents submitted to regulatory agencies (e.g., INDs, NDAs, BLAs, MAAs, Meeting Briefing Packages, IBs, Annual Reports, etc.) and other documents supporting strategic development.
Timely support to respond to inquiries and questions from regulatory authorities
Provide global regulatory updates and newsletters for both internal staff and our clients. Advising clients on and/or providing interpretation of relevant regulatory requirements (e.g., for FDA, Health Canada, EMA, China etc.).
Collaborating cross-functionally with other organizational practice areas (e.g., CMC); communicating with clients and project managers regarding technical issues, timelines, deliverables, etc.
Monitoring and staying up-to-date on scientific advancements, regulatory requirements, and industry trends relevant to nonclinical research and development in the pharmaceutical industry
Identifying and pursuing new business opportunities, leading to the expansion of WuXi Bio’s regulatory affairs services and contributing to the overall growth of RA teams.
Providing training and mentorship to internal staff, clients, and external vendors as needed.
Other duties as assigned.

Qualifications

Minimum of 6 years regulatory or equivalent experience within a device or pharmaceutical company, CRO, or similar organization and a Ph.D. in Pharmacology and Toxicology, or closely related discipline.
Practical experience in preparation of dossiers in CTD format and regulatory submission to major regulatory agencies, including US FDA, Canada, EMA, TGA, China, etc. Manage multiple projects and deadlines
Knowledge of regulatory guidelines and requirements and experience with nonclinical pharmacology/toxicology strategy development, study design, data interpretation and risk assessment.
Experience interacting with the regulatory authorities, such as FDA/EMA/CDE, on IND/BLA
Strong interpersonal skills with the ability to develop partnerships and relationships throughout the organization as well as with key external stakeholders. Excellent written and verbal communication skills with the ability to listen, articulate and advocate
Dedicated and self-motivated, honest, open and transparent. Ability to work independently and in a team environment
Prior experience in a global working environment is not a must but a plus.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

Apply now