Associate Director, Global Regulatory Affairs
BioSpace, Weston, Massachusetts, United States, 02193
Associate Director, Global Regulatory Affairs
6 days ago Be among the first 25 applicants
Company Overview ModeX Therapeutics, an OPKO Health company, is the leading clinical‑stage biopharmaceutical company developing unique and proprietary‑multispecific therapeutics. Its MSTAR platform unites the power of multiple biologics in a single molecule to create multispecific antibodies that bind four or more targets with unprecedented versatility and potency for complex diseases. Its promising first‑in‑class immunology pipeline includes candidates against immune diseases, including cancer (both solid and hematologic tumors), immune impairment, as well as several of the world’s most pressing viral threats. Its founding team includes globally recognized medical innovators with proven track records of delivering breakthroughs for patients. ModeX is based in Weston, Massachusetts. For more information, please visit www.modextx.com.
Job Description The Associate Director, Global Regulatory Affairs, is responsible for the development and implementation of regulatory strategies for specific early‑stage drug development programs, while serving as the regulatory lead on the respective program teams. The Associate Director will also be the regulatory contact with relevant regulatory authorities, as appropriate. The key to success will include working across cross‑functional teams, working collaboratively with stakeholders, project leaders, and project team members, and driving the execution of integrated development plans for drug candidates.
Key Responsibilities
Prepare and support submission to successful filing and approval for clinical trial submissions
Develop various briefing packages and regulatory applications (e.g., orphan, expedited review pathways, etc.) to the FDA and other global health authorities, as applicable
Develop response and submission strategies to regulatory information requests in close collaboration with cross‑functional team members
Partner with project team leaders and functional leaders to define project strategy, develop and maintain integrated project plans, and manage diverse teams across multiple sites to meet project timelines/goals
Continuously adapt project strategy based on internal and external information
Identify and assess regulatory risks for assigned projects or programs
Serve as a Health Authorities contact for the assigned projects and contribute to Health Authority meetings
Foster effective, proactive and open communication within and across project teams, build mutual respect and trust among team members to achieve transparency and clarity of program goals, progress and issues
Contribute to development and improvement in processes, procedures, and tools related to regulatory affairs practices
Essential Requirements
Master's in life sciences required, advanced degree (PharmD, MD, PhD) preferred
7–10+ years of relevant progressional experience, with 5+ years of regulatory affairs experience in immunology, oncology or rare diseases
Previous track record of success working with multidisciplinary drug development teams and managing international development projects
Demonstrate strong organizational skills, including the ability to prioritize topics and workload
Strong interpersonal skills and the ability to deal effectively with a variety of personnel (e.g., clinical, scientific, QA and CMC staff)
Experience in interfacing with relevant regulatory authorities
Experience and knowledge in the preparation of regulatory documents, including interpretation of regulations, guidelines, policy statements, etc.
ModeX Therapeutics is an Equal Opportunity Employer #J-18808-Ljbffr
Company Overview ModeX Therapeutics, an OPKO Health company, is the leading clinical‑stage biopharmaceutical company developing unique and proprietary‑multispecific therapeutics. Its MSTAR platform unites the power of multiple biologics in a single molecule to create multispecific antibodies that bind four or more targets with unprecedented versatility and potency for complex diseases. Its promising first‑in‑class immunology pipeline includes candidates against immune diseases, including cancer (both solid and hematologic tumors), immune impairment, as well as several of the world’s most pressing viral threats. Its founding team includes globally recognized medical innovators with proven track records of delivering breakthroughs for patients. ModeX is based in Weston, Massachusetts. For more information, please visit www.modextx.com.
Job Description The Associate Director, Global Regulatory Affairs, is responsible for the development and implementation of regulatory strategies for specific early‑stage drug development programs, while serving as the regulatory lead on the respective program teams. The Associate Director will also be the regulatory contact with relevant regulatory authorities, as appropriate. The key to success will include working across cross‑functional teams, working collaboratively with stakeholders, project leaders, and project team members, and driving the execution of integrated development plans for drug candidates.
Key Responsibilities
Prepare and support submission to successful filing and approval for clinical trial submissions
Develop various briefing packages and regulatory applications (e.g., orphan, expedited review pathways, etc.) to the FDA and other global health authorities, as applicable
Develop response and submission strategies to regulatory information requests in close collaboration with cross‑functional team members
Partner with project team leaders and functional leaders to define project strategy, develop and maintain integrated project plans, and manage diverse teams across multiple sites to meet project timelines/goals
Continuously adapt project strategy based on internal and external information
Identify and assess regulatory risks for assigned projects or programs
Serve as a Health Authorities contact for the assigned projects and contribute to Health Authority meetings
Foster effective, proactive and open communication within and across project teams, build mutual respect and trust among team members to achieve transparency and clarity of program goals, progress and issues
Contribute to development and improvement in processes, procedures, and tools related to regulatory affairs practices
Essential Requirements
Master's in life sciences required, advanced degree (PharmD, MD, PhD) preferred
7–10+ years of relevant progressional experience, with 5+ years of regulatory affairs experience in immunology, oncology or rare diseases
Previous track record of success working with multidisciplinary drug development teams and managing international development projects
Demonstrate strong organizational skills, including the ability to prioritize topics and workload
Strong interpersonal skills and the ability to deal effectively with a variety of personnel (e.g., clinical, scientific, QA and CMC staff)
Experience in interfacing with relevant regulatory authorities
Experience and knowledge in the preparation of regulatory documents, including interpretation of regulations, guidelines, policy statements, etc.
ModeX Therapeutics is an Equal Opportunity Employer #J-18808-Ljbffr