Director of Regulatory Affairs (Remote)

Location: Lexington,Massachusetts,United States

DIRECTOR OF REGULATORY AFFAIRS 

Partner Therapeutics is a commercial biopharmaceutical company committed to improving the lives of patients with cancer and other serious diseases. Our dedicated team brings a rigorous approach to science, establishes deep partnerships with medical and scientific communities, and works tirelessly to expand potential treatment options and address unmet medical needs.

POSITION SUMMARY

The Director of Regulatory Affairs is responsible for providing global strategic and operational direction for the planning, management, support, and execution of regulatory activities. With oversight from the Head of Regulatory Affairs, this person independently leads the preparation and formulation of strategy for global regulatory submissions in collaboration with cross-functional team members and management. This position acts as the regulatory affairs point of contact for interactions with Health Authorities (HAs) and cross-functional team members and may lead team(s) in orchestrating Health Authority interactions.

PRIMARY RESPONSIBILITIES

• Contributes to the development and implementation of clinical, pre-clinical, and regulatory strategies for projects in all stages of development (pre-IND/IMPD through NDA/BLA/MAA).
• Works cross-functionally with clinical, manufacturing, commercial, and CROs on regulatory affairs related issues.
• Flexibility to adapt and contribute in various capacities, as needed, within areas of expertise (e.g., clinical development, document writing, pharmacovigilance).
• Serves as a primary liaison to US FDA, EMA, and other key market Health Authorities for assigned projects.
• Defines strategies for, coordinates the execution of, and ensures the proper archival of regulatory submissions including, but not limited to, Clinical Trial Applications (CTAs), Investigational New Drug Applications (INDs), Biologics Licensing Applications (BLAs), New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
• Develops strategies and drafts and/or reviews responses and other documents intended for submission to Health Authorities including, but not limited to, information requests, meeting requests, briefing packages, fast track applications, orphan drug applications, and breakthrough therapy designation applications. 
• Integrates global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents.
• Manages the completion of documents and other assigned tasks within established timelines and with high quality.
• Through self-education and external networking/participation in industry and professional organizations maintains awareness of developing views/guidance within FDA and EMA on general and specific topics related to the therapeutic area and other development projects as appropriate. Actively applies learned best practices, knowledge, and benchmarking to PTx projects and solutions.
• Resolves issues by ensuring timely issue escalation to Leadership and cross-functional teams: Applies learning from these events and leads the creation of new/updated systems, processes, programs to prevent similar situations in the future.
• Adheres to all applicable regulations and requirements including compliance with internal SOPs, GMP, Health and Safety, WISHA/OSHA, regulatory compliance, company policies, and employment-related laws and statutes.
• Successfully completes all mandatory Quality and Compliance training within required timeframes.
• This job description is not intended to be all-inclusive. Partners may be required to perform other related duties as required to meet the ongoing needs of the organization.

KNOWLEDGE, SKILLS, ABILITIES

Required:

• Full functional knowledge of US regulatory requirements pertaining to the development and registration of biological/small molecule drug products
• Experience with IND and NDA/BLA filings
• Experience communicating with the FDA and organizing FDA meetings
• Experience with launching new products, working with FDA advisory committee meetings, or labeling negotiations is a plus
• Proven ability to manage complex projects. Possesses strong organizational and prioritization skills to maintain a high level of productivity and priority-setting in order to complete assignments on-time and on-budget.
• Strong critical thinking, analytical, and problem-solving skills with the proven ability to formulate solutions to propel the organization forward.
• Resourceful with proven ability to lead, manage, and leverage an extensive internal network of stakeholders, team members, and external resources to plan and resolve issues.