Regulatory Operations Specialist (Remote)

Description

REGULATORY OPERATIONS SPECIALIST (Remote)

Partner Therapeutics (PTx) 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 Regulatory Operations Specialist IV is a regulatory professional with project management capabilities responsible for leading and/or contributing to the end-to-end planning, coordination, and execution of assigned deliverables. The Specialist manages delivery of submissions to time, quality, and in compliance with applicable regulations. The individual leads and develops submission documents, using templates, including cover letters, forms, and routine right-to-operate documents (annual reports, semi-annual reports, etc). Management of regulatory systems and tools, including filing of regulatory communications are expected.

Primary Responsibilities

• Leads development and implementation of standards for publishing, archiving, metrics and submission process to global health authorities
• Supports and facilitates a solid team effort in meeting company goals.
• Provides operational oversight and support for planning, preparation, tracking, publishing, QC, validation, and timely submission of eCTD submissions to global health authorities (e.g. IND, NDA, BLA, MAA, etc.).
• Manages communications and activities with third-party publishers and regulatory vendors.
• Looks for opportunities to assist regulatory scientists in their day-to-day strategic work.
• Manages and indexes archives of regulatory submissions; manages and files regulatory correspondence.
• Supports budgeting and forecasting activities, including managing expenditures related to approved vendor contracts. Ensures appropriate regulatory contracts are executed/renewed on time.
• Ensures all submission documents are compliant with eCTD specifications, including template styles, fonts, margins, etc.
• Leads regular submission planning meetings, maintains submission calendar/timeline and submission forecasting, including long term planning for submission deliverables.
• Independently develops and leads regulatory submission documents, including cover letters, forms, and routine right-to-operate documents (annual reports, semi-annual reports, etc.).
• Sets-up and trains cross-functional team members ensuring proficiency in Veeva collaborative authoring system and StartingPoint templates (or similar systems/tools).

Knowledge, Skills, Abilities

• Proven ability to work independently and with minimal oversight. A pro-active work style is required: Possesses the ability to see what needs to be done next and how those decisions effect subsequent steps. Confident asking questions when unsure.
• Familiarity with Veeva Vault – RIM, Sharepoint, and publishing software strongly preferred. Sophisticated MS-Office skills required.
• Understands the need and how to create well-organized systems and documentation to enable finding documents from the distant past, present, and future.
• Proven ability to plan, develop, evaluate, analyze and interpret reports and other documents for regulatory submissions.
• Regulatory submissions experience, both pre- and post-marketing. Specific experience with clinical, and CMC are required; familiarity with labeling submissions is desirable. Direct experience interacting with FDA is desirable.
• Strong relationship management, analytical, and interpersonal skills required to quickly gain confidence of stakeholders and team members required.
• Strong organizational skills enabling the management of multiple, simultaneous submissions often with different team members and different timelines.
• Detail-orientation where the individual can pick up subtle issues and differences, understands nuances and rationale for one path versus another.
• Interest in and ability to expand areas of regulatory expertise.
• Effective written, oral, and interpersonal skills are required for this highly collaborative role. Skilled at leading effective meetings and making presentations when required. Possesses writing skills sufficient to create documents and reports for regulatory submissions and compliance.
• Demonstrated sound problem-solving skills including using creative approaches to resolve unique issues. Possesses strategic and operational capabilities with ability to "think outside the box".
• Formal project management training optimal; practical project management skills and recent application required.
• Energetic with willingness and ability to roll up your sleeves and work hands-on, to adapt and respond to a rapidly changing environment.

Required

EXPERIENCE & EDUCATION

• 8+ years of progressively responsible regulatory operations/affairs experience in the pharmaceutical or biotechnology industry required.
• High School diploma or GED.

Preferred

• MS or other advanced degree optimal.
• B.S. or equivalent degree in science (Biology, Chemistry, Biochemistry, etc.) or related field optimal.

PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for this position is $111,000 - $158,000: 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.