Location: Waltham,MA, USA
Company Overview:
Innoviva Specialty Therapeutics, Inc. (IST), a subsidiary of Innoviva, Inc., is a biopharmaceutical company developing and delivering innovative therapies in critical care and infectious disease. IST is uniquely positioned to advancing solutions for the most critical and urgent infections identified by the world's leading public health organizations. Our approved treatments are indicated to address high unmet medical needs for serious conditions, and our investigational therapies are in development for patients fighting drug-resistant pathogens. IST currently has three marketed medicines - GIAPREZA (angiotensin II) a vasoconstrictor, for the treatment of refractory hypotension in adults with septic or other distributive shock; XERAVA (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) and XACDURO (sulbactam for injection; durlobactam for injection), approved as the first pathogen-targeted antibacterial approved by the US FDA to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. Our investigational drug, Zoliflodacin is a potential first-in-class, orally administered, single dose antibiotic with a novel mechanism of action that is currently in development for the treatment of uncomplicated gonorrhea. At IST, we are building a culture dedicated to delivering products that address critical medical needs. If this is your passion, come and join us to make differences for patients.
Summary of Position:
The Manager of Regulatory Operations is accountable for the preparation, publishing, review, submission, maintenance, and archiving of Regulatory Dossiers. This role will be managing routine and nonroutine publishing and submission activities for IST portfolio and providing support for all Health Authority (HA) submission-related activities including compilation of submission-ready documents, publishing output or overseeing the creation of quality submission output in-house or by outsourced vendors, and the transmission of submissions to the HA. This individual should be knowledgeable in regulatory publishing and ensures that all regulatory submissions performed are compliant with HA regulations. This individual provides technical expertise to cross-functional submission project team. In addition, this individual contributes to supporting the IST's regulatory related infrastructure systems such as Veeva Vault Regulatory Information Management (RIM) maintenance and management of other Regulatory related systems.
Responsibilities:
Provides operational support to key functions within the Regulatory Affairs team and across the organization. This includes planning, preparation, publishing, publishing review and validation and timely submission to global HA
* Negotiates and agrees on realistic dates and timelines for document handoffs, publishing and submission in collaboration with authors and publishers (in-house or outsourced vendors)
* Oversees publishing and submission (in-house or outsourced vendors) and maintenance of all HA submissions including but not limited to initial Investigational New Drugs (IND), Meeting Request/Meeting Packages, IND Amendments, Annual Reports, Safety Reports, Development Safety Update Reports (DSUR), New Drug Application (NDA) etc.
* Creates Study Tagging Files and publishes datasets
* Prepares, formats, and performs QC on published documents (i.e., hyperlinking, bookmarking)
* Participates in validation activities (i.e., User Acceptance Testing) for the implementation of technology systems related to Regulatory (Publishing, EDMS, etc.)
* Supports colleagues with formatting and submission readiness activities
* Maintains proficiency in Veeva Vault RIM and maintain current knowledge of regulations, best practices, and guidelines related to RIM
* Maintains Veeva Vault RIM system and ensures that content plans and regulatory records are up to date for lifecycle submission management through Veeva Vault RIM
* Manages user groups and workflows in Veeva Vault RIM and creates and maintains archives of Health Authority interactions
* Contributes to the writing, review, and implementation of standard operating procedures (SOPs) related to regulatory affairs
* Participates and shares lessons learned sessions to encourage process improvement
* Monitors the development of new regulatory requirements or guidance documents and provide advice to teams on impact on the business
Experience & Education:
* Bachelor's degree is required. Advanced degree (PharmD; MSc.) in a scientific discipline is preferred.
* 5 plus years in life sciences industry with at least 3 years of Regulatory publishing and submission management experience in leading successful applications management.
Skills and Abilities:
* Advanced skills in using Regulatory Information Management Systems (RIMS), preferably Veeva Vault RIM, to maintain compliance with all applicable regulations. Will act as trainers for new users. Experience working with PromoMat is a plus
* Excellent competency in Electronic Document Management Systems (EDMS), eCTD publishing tools, and relevant IT platforms that support regulatory operations.
* Experience publishing for FDA applications is required; experience in other regions outside of U.S./FDA is desirable.
* Proficiency with MS-Office Suite and Adobe Acrobat, including PDF plug-ins that support submission readiness. Knowledge of MS Word Templates, their function and usage. Working knowledge of Adobe Acrobat PDF Bookmarks and Hyperlinks.
* Knowledge of StartingPoint templates. Will act as trainers for new users.
* Solid experience with SharePoint technology (TEAMS)
* Ability to troubleshoot issues related to template use and other technical challenges in regulatory submissions.
* Ability to create FDA account for ESG submission and other systems involving Regulatory Operations
* Proven ability to lead and manage complex projects, ensuring timely delivery of regulatory submissions such as understanding submission deliverables dependencies and ability to create and maintain
* detailed submission schedule and submission content plan
* Knowledgeable in Module 1 specifications for various regions and Module 2 through 5 specifications
* Highly knowledgeable in CTD/eCTD structure and requirements and very good understanding of submission requirements for global submissions (i.e., IND, NDA, MAA, NDS, CTA etc.)
* Ability to multi-task and work independently as well as collaboratively on a team with evolving timeline and priorities
* Experience in planning, tracking, assembling, and submitting regulatory documents in collaboration with internal teams and external vendors.
* Skilled in coordinating and overseeing outsourced vendor activities to ensure quality and compliance of submissions.
* Strong ability to communicate effectively both written and verbal, across various levels of the organization, such as training team members and presenting complex regulatory requirements in an understandable manner and with external stakeholders such as FDA
* Competent in interpreting and applying regulatory guidelines and standards to practical scenarios within the company.
* Meticulous attention to detail with a strong focus on quality and compliance in all aspects of regulatory submissions.
* Strong working knowledge of submission requirements and guidelines for all submission types, both paper and electronic and strong experience in the regulatory submission process.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Innoviva Specialty Therapeutics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.