Partner Therapeutics

POSITION SUMMARY

The Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs Contractor is responsible for providing services and expertise in support of CMC regulatory activities across the product lifecycle, in line with US, European, and other applicable regulations.

This position is a REMOTE role supporting our Lynnwood, WA plant which is a cGMP production scale manufacturing facility for our product, Leukine® (sargramostim), a therapeutic glycoprotein.  The Contractor is expected to work up to 20 hours per week, and be available for meetings and business discussions during core business hours as established by their People Leader.

PRIMARY RESPONSIBILITIES

• Provides guidance to cross-functional teams on CMC regulatory strategy and regulatory requirements and  serves as  a key interface between CMC subject matter experts (SMEs) and Regulatory Affairs.
• Develops and executes filing strategies for CMC updates with a strong focus on analytical, manufacturing, and facilities compliance.
• Delivers high quality, submission-ready CMC modules to internal and external partners in compliance with Partner Therapeutics’ systems and procedures.
• Supports life cycle management and generation of submission-ready content of the Quality sections of the CTD, maintaining compliance with applicable requirements.
• Manages the preparation and delivery of CMC documents throughout their product lifecycle.
• Tracks and communicates Health Authority status during review and final outcomes.
• Supports the established strategy to employ fit-for-purpose content, applying regulatory intelligence to optimize proposed submission content.
• Participates in Regulatory team meetings and communicates relevant updates to CMC teams.
• Participates in Change Control Board discussions in evaluating proposed CMC changes and regulatory requirements.
• Resolves “stuck" 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 and programs to prevent similar situations in the future.
• Adheres to all applicable regulations and requirements including compliance with internal SOPs, GMP, Health and Safety, 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:

• Understanding of CMC regulatory guidelines and ability to explain content to stakeholders.
• Experience preparing regulatory right-to-operate documents (e.g., annual reports, biological product deviation report, etc.).
• Experience authoring CMC submissions (i.e., CBE-0, CBE-30, PAS).
• Experience reviewing regulatory correspondence with Health Authorities, Quality submissions, annual reports, etc. to assure regulatory requirements met.
• Experience in Veeva and knowledge of workflows and processes
• Strong critical thinking, analytical, and problem-solving skills with the proven ability to formulate solutions to propel the organization forward.
• 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.
• Resourceful with proven ability to influence 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.
• 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.
• 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.
• Proficiency with MS Office products, especially Word and Excel, is essential; ability and willingness to quickly adopt other job-specific applications will be necessary.

Preferred:

• Software application experience with Smartsheet, MS Project, and SharePoint.
• Project management experience or formal training.

EXPERIENCE & EDUCATION

Required:

• High School Diploma or GED.
• 10+ years of progressively responsible Regulatory experience working in a GMP environment or other regulated industry.
• Broad knowledge of CMC regulatory affairs and regulatory guidance.

Preferred:

• Bachelor's Degree in Biochemistry, Chemistry, Life Sciences, or Pharmacy.

PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for the Associate Scientist position is $90.00 - $100.00: 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.

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.