Regulatory Operations Manager

POSITION SUMMARY
The Regulatory Operations Manager is a regulatory professional with deep regulatory affairs and operations expertise and project management capabilities responsible for leading and contributing to the end-to-end planning coordination and execution of planned deliverables. The Manager represents the Regulatory Operations business SME and has a strong understanding of regulatory information management (RIM) systems authoring and publishing tools data organization authoring processes eCTD requirements and document writing and formatting.

PRIMARY RESPONSIBILITIES

Required:

• 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.) across the entire product lifecycle.
• Independently develops regulatory submission documents including cover letters and forms for standard submission ensuring accuracy of content.
• Leads and coordinates cross-functional teams during routine right-to-operate submissions (annual reports semi-annual reports LDR PMPRB etc.).
• Ensures applications and dossiers are prepared to the highest quality standard.
• Coordinates setup of RIM authoring templates and authoring toolbar and trains internal and external cross-functional team members ensuring proficiency in RIM collaborative authoring.
• Trains and supports internal and external RIM system contributors on the RIM system author and review processes and document formatting.
• Ensures all submission documents are compliant with eCTD technical specifications including template styles fonts margins etc. according to regional regulatory requirements.
• Oversees submission management and activities and coordinates with PTx colleagues third-party publishers and regulatory vendors.
• Manages and indexes archival activities of regulatory submissions; manages and files regulatory correspondence.
• Anticipates regulatory obstacles and emerging issues and develops solutions and regulatory strategy accordingly.
• Leads development and implementation of standards for publishing archiving metrics and submission process to global health authorities.
• Leads regular submission planning meetings with Regulatory Affairs partners maintains planned submission calendar timelines and submission forecasting including long-term planning for submission deliverables.
• Negotiates submission timing with Reg Affairs cross-functional teams and publishing vendor when multiple submission timelines compete.
• Under the Business Administrator role within the RIM system maintains system structure (e.g. products applications submissions regulatory objectives clinical trials and all associations etc.) to accommodate submission requirements and business needs.
• Coordinates with external vendors RIM software Managed Services IT and Quality Systems to maintain troubleshoot enhance test and validate the RIM system.
• Reviews and updates the RIM user list and available licenses.
• Supports budgeting and forecasting activities including managing expenditures related to approved vendor contracts. Ensures appropriate regulatory contracts are executed/renewed on time.
• Monitors and directs the usage of purchased RIM Managed Services hours vendor billing (RIM publisher and other tools) and reduces expenditures where possible.
• Cultivates vendor relationships and implements Vendor Relationship Management (VRM) to control costs mitigate risks and improve service.
• Supports and facilitates a collaborative team effort toward meeting Company goals with alignment of PTx values and behaviors.
• Proactively looks for opportunities to support regulatory scientists and cross-functional contributors in their day-to-day strategic work.
• Partners with CMC team Clinical Business Development Promotional and Labeling colleagues and other regulatory strategists and project management colleagues to assure consistent and appropriate regulatory strategy project management and submissions support including other relevant cross-functional areas (e.g. Pharmacovigilance Safety Commercial Medical/Clinical Nonclinical R&D Legal etc.).
• Authors and updates SOPs develops training to ensure compliance and leads process improvements to maximize efficiency.
• Through self-education and external networking/participation in industry and professional organizations keeps abreast of current industry trends compliance requirements and best-of-class technologies relating to area of responsibility. Actively applies learned best practices knowledge and benchmarking to PTx projects and solutions.
• This position may have oversight of other Regulatory Operations personnel.
• Adheres to all applicable regulations and requirements including compliance with internal SOPs GMP Health and Safety OSHA regulatory compliance Company policies and employment-related laws and statutes.

KNOWLEDGE SKILLS ABILITIES

Required:

• Regulatory submissions knowledge both pre- and post-marketing. Specific knowledge of clinical and CMC are required; familiarity with labeling submissions is desirable. Direct experience interacting with FDA is desirable.
• 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.
• 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.
• 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.
• Proven ability to work independently with minimal oversight. A proactive 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.
• 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.
• 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.
• 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.
• Interest in and ability to expand areas of regulatory expertise.
• Familiarity with Veeva Vault RIM Sharepoint and publishing software strongly preferred.
• Sophisticated MS Office skills required especially Word and Excel; ability and willingness to quickly adopt other job-specific applications will be necessary.

EXPERIENCE & EDUCATION

Required:

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

Preferred:

• Bachelors degree in Pharmaceutical Biological or related field.

PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for this position is $123500 - $150000: 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 Years 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.