Associate Director, Regulatory Affairs (Contract)

• →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.

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.
• Effective oral and written communication
• 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.

Skills: 

• Proficiency with Microsoft Word, Outlook, SharePoint, and Adobe Acrobat
• Excellent written and verbal communication skills
• Strong organizational skills
• Knowledge of GCPs, GLPs and GMPs

Base salary compensation range: $83.00 - 98.00 

Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.