GENERAL SUMMARY:

We are seeking an experienced Associate Director, Regulatory Affairs (Contract) focusing on the management of CMC and clinical regulatory applications (domestic and international) in support of 4DMT’s multiple therapeutics in development. The role requires working closely with 4DMT’s key stakeholders, cross-functional teams, partners, contract research organizations, and global health authorities to ensure rapid review and approval of clinical trial applications, and other regulatory filings. Expertise in complex biologics and/or gene therapy is highly desirable. Experience with late-stage, Phase 3 development is preferred. Experience with regulatory interactions and/or submission to PMDA (Japan), CDE (China) or other international regions is preferable. This position is also responsible for obtaining and interpreting regulations and guidance and providing regulatory advice to clinical departments. Strong communication and management skills are required.

This role can be in-person, remote or hybrid.

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.
• 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.