Director of Regulatory Affairs (Remote)

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. Strong, collaborative relationship management and interpersonal skills required to quickly gain confidence of stakeholders and team members.
• Excellent soft skills including a bias towards action, the ability and willingness to give and receive constructive feedback, is comfortable working within a diverse team and across multiple functions, exhibits a consistently constructive attitude, and is adaptable and at ease with handling unexpected changes and challenges.
• Proven ability to make effective and persuasive presentations on complex topics to management and external audiences.
• Solid English language communication skills, both oral and written, are required for this highly collaborative role. Willingness and ability to clearly express opinions and ask questions.  Comfortable actively participating in cross-functional meetings.
• Proficiency with MS Office products, especially Word and Excel essential; ability and willingness to quickly adopt other job-specific applications will be necessary.

Preferred:

• Previous experience in leading submission teams for marketing and/or clinical trial applications is a plus
• Previous experience in Veeva Rim and document template systems is a plus
• Software application experience with Smartsheet, MS Project, and SharePoint.
• Project management experience or formal training.

PEOPLE LEADERSHIP QUALIFICATIONS

Required:

• Although this position currently does not directly manage PTx Partners, the individual will lead others who are members of their various project teams as well as external vendors and consultants.

Preferred: 

• Proven ability to manage and motivate a diverse team without direct line management responsibility.
• In collaboration with their People Leaders, coaches and mentors team members in support of their individual development and overall performance of the team.
• Skilled at active listening, conflict resolution, and team building.

EXPERIENCE & EDUCATION

Required:

• 12 years of progressively responsible regulatory experience in the biotech/pharmaceutical industry
• BA, BS, or equivalent degree in a science-based discipline required.

Preferred:

• An advanced degree (PharmD, PhD, MS, etc.) in a science field is strongly preferred
• Previous experience working in mid-size, entrepreneurial organization(s) as well as multi-national pharma

PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for this position is $187,000 - $255,000: Offers are made within the base pay range applicable at the time. Your salary will vary depending on several factors including your qualifications and experience.

In addition to medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage, all full-time, regular Partners enjoy a casual, and Hybrid or Remote workplace program for many roles.  We offer a terrific compensation/benefits/perks package which includes pre-IPO options, annual cash bonuses, 401k matching, free parking or Seattle-area ORCA pass, tuition assistance, plus rewards for achievement and contribution. To support a healthy work-life balance we also provide a gym subsidy, wellness participation programs, and a generous vacation, sick, and holiday paid time off program in addition to a paid shutdown between the Christmas and New Year’s holidays.  

Partner Therapeutics is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, age, national origin, veteran status, marital status, sexual orientation, gender identity, disability or any other category prohibited by local, state, or federal law. This policy applies to all aspects of employment, including recruitment, placement, promotion, transfer, demotion, compensation, benefits, social and recreational activities, and termination.  

Salary : $187,000 - $255,000