Associate Director, Regulatory Affairs (Contract)

Responsibilities

• Communicate with regulatory agencies regarding submission strategies, regulatory pathways, and responses to agency correspondence.
• Oversee planning, preparation, and submission of the regulatory documents (protocols, investigator brochures, CMC and nonclinical sections of clinical trial applications) for a Phase 3 clinical trial in Japan and China.
• Ensure that the sections are complete, well-written, and meet all relevant requirements.
• Develop excellent relationships with internal functional groups, contract research organizations, and partners.
• Provide regulatory advice to clinical operations, CMC and pharmacology/toxicology departments based on knowledge of current requirements.
• Manage responses to questions and interactions with regulatory authorities for assigned projects.
• Respond to agency questions and requests for information.

Qualifications

• Education: B.Sc. minimum
• Experience: 5-8 years of experience in Regulatory Affairs or a related discipline in the pharmaceutical or biotechnology industry (preferably with exposure to the development phase of the product lifecycle)
• Experience in filing clinical trial applications for pharmaceutical, gene therapy or biologic products in the US, China or Japan is desired, but not required
• Thorough understanding of relevant drug development regulations and guidelines
• Outstanding interpersonal and communication (written and verbal) skills; proficient with computer and standard software programs
• Knowledge of the drug development process and global regulations and requirements required
• Strong analytical skills, problem solving ability and presentation skills required
• Flexibility and ability to prioritize and manage multiple tasks simultaneously
• Aid in development of departmental policies and oversees their implementation
• Applies strong analytical and business communication skills
• Knowledge of GCPs, GMPs, GLPs (FDA, ICH, and ISO) requirements and other regulatory guidelines
• Ability to work independently in a dynamic and changing company environment
• Established track record of clinical Regulatory decision-making
• Ability to multi-task and support more than one project simultaneously
• Ability to work in a team-based environment, cooperatively and supportive of multiple viewpoints and approaches
• Strong organizational skills