Senior Manager/Associate Director, Regulatory Affairs and Operations
Dova is a clinical-stage pharmaceutical company developing treatments for patients suffering from orphan diseases. The company’s lead investigational compound, avatrombopag, is in the process of completing two pivotal Phase 3 clinical trials researching its use as a potential treatment for thrombocytopenia in patients with chronic liver disease undergoing an elective procedure. For more information on the company visit www.dova.com.
Responsibilities will include, but are not limited to, the following:
This role will include both regulatory operations and regulatory affairs responsibilities. The ideal candidate will have experience relevant to both functions.
- Provides oversight of the planning, preparation, publishing, validation and timely submission of applications (IND, BLA, MAA, etc.), annual reports, updates, amendments, and variations to domestic and global regulatory agencies.
- Develops and implements strategies for high quality compliant regulatory submissions (eCTD, etc.), including clinical trial applications, investigational new drug applications and marketing applications globally.
- Prepare documentation for routine regulatory submissions (cover letters, regulatory forms, etc)
- Leads the dossier management and standardization activities. Responsible for harmonization of procedure and regulatory data management.
- Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Development Teams and Study Teams, etc.
- Monitors the development of new regulatory requirements or guidances, and provides advice to product teams of the impact on the business.
- Oversees development and implementation of standards for publishing and submission process for global regulatory authorities
- Oversees maintenance of all technologies and infrastructure (BOX, SharePoint, etc.) needed to facilitate collaboration with vendors, partners, and other functions
- Oversees compliant archiving of all regulatory documents with permissions in place for access
- Assesses impact of standards and requirements with a regional impact to existing and new systems.
- Responsible for regulatory submission process improvements and establishing repeatable processes utilizing key technologies
- Assists leadership in advising company on optimal submission strategy. Assists in actively engaging external and internal initiatives
- Works with leadership to oversee strategic implementation of outsourcing services
- Ensures SOP adherence, application of best practices, oversight of CRO, and customer/stakeholder interactions, and overall vendor management activities.
- Coordinates activities related to Structured Product Labeling components of marketed products, including establishment registration, labeling, labeler codes, etc.
- A minimum of 10 years of experience in regulatory affairs/operations within the pharmaceutical industry.
- Strong verbal and written communication and presentation skills.
- Strong interpersonal skills and ability to work effectively and build relationships with cross-functional teams.
- Knowledgeable in CTD/eCTD structure and requirements and a solid understanding of submission requirements for US submission types (e.g. IND, DMF, NDA, PSUR etc.).
- Strong knowledge of Microsoft Office suite, Adobe Acrobat, electronic document management systems, and viewing tools. Solid experience and knowledge of SharePoint technology is desired.
- Demonstrated leadership, organizational and planning skills.
- Ability to multi-task, pay close attention to detail, and follow projects through to completion to meet deadlines.
- Ability to work independently (with minimal supervision), as well as work in a team environment with changing timelines and priorities.
- Excellent written and verbal interpersonal skills are required; these must be effectively used to influence many diverse internal and external customer groups.
- Must be able to adhere to strict project timelines and budgets, and to advise teams and management of impacts and changes in project time-lines.
- Ability to manage changing departmental priorities, evaluate and assign resources, and communicate timeline and resource impacts to project teams and management is required.
- Occasional domestic and International travel may be necessary
To apply please send CV and letter of interest to email@example.com