What are the responsibilities and job description for the Associate Director, Global Regulatory Affairs position at BioSpace?
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 Include But Are Not Limited To
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 Include But Are Not Limited To
- 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 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
- 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, including interpretation or regulations, guidelines, policy statements, etc.