Job Description
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.
4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery
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.
4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
