Venatorx Pharmaceuticals, Inc
Sr Mgmt - R&D/Ops
Malvern, PA, US
The VP, Regulatory Affairs is responsible for providing overall leadership to ensure development and execution of regulatory strategies and plans to enable efficient global development of products in the portfolio. (S)he is tasked with providing ongoing analysis of regulatory risks and opportunities in the development programs and proposing innovative approaches to mitigate/resolve risks and leverage opportunities to the benefit of the company’s development efforts. (S)he will also be accountable for effective regulatory submissions and communications/meetings across these territories, as well as developing the in-house and contracted infrastructure and capability to maintain compliance with all regulatory requirements applicable to the company’s programs. Additionally, (s)he will lead strategic initiatives within the regulatory affairs organizations and continue to build or optimize capability across all relevant regulatory subdisciplines including regulatory CMC and operations to achieve evolving business goals.
The VP, Regulatory Affairs will advise internal development functions such as Clinical, Medical, Nonclinical and CMC regarding regulatory impact of development decisions. (S)he will work collaboratively with Quality Assurance to ensure quality systems and compliance are maintained. (S)he will support business development activities including assessing partnership/in-licensing/out-licensing opportunities, collaborate with strategic and government partners, and support government affairs/advocacy activities.
- Provide strategic direction to Regulatory Affairs department; lead Regulatory Affairs group, including hiring, mentoring and leading staff.
- Provide regulatory leadership and support to project/program teams and Senior Management for all aspects of the development program (nonclinical, clinical, quality (CMC) and labeling).
- Effectively communicate requirements and compliance obligations under laws, regulations, and guidance in the US and around the world.
- Develop and maintain regulatory affairs infrastructure including development of departmental policies and procedures.
- Direct and negotiate submissions (IND, CTA, NDA, MAA etc..) and approvals with regulatory authorities.
- Guide and/or lead regulatory agency interactions, including communications and meetings.
- Strategize, lead, write and/or supervise the development of and submission of documents/dossiers to regulatory agencies to achieve development goals; ensure on-time, high-quality and regulatory–compliant submissions.
- Coordinate safety review processes to ensure an ongoing risk/benefit assessment of all development combination products, and timely reporting of safety issues to the FDA, and other parties as needed.
- Provide support to regulatory reviews for due diligence initiatives, including opportunity and risk assessment.
- Contribute to the creation of the overall product development strategy and manage the development, monitoring and delivery of regulatory project plans throughout the life-cycle.
- Responsible for cost-effective management of the Regulatory Affairs department budget.
- Advanced degree in a scientific discipline (M.D., Ph.D., PharmD) preferred, with at least 15 years of relevant regulatory experience; other degrees (B.S., M.S., MBA) will be considered with appropriate experience.
- Experience supporting both early and late phase development, including development and filing of associated regulatory submissions.
- Experience managing and collaborating with outside partners/vendors.
- Ability to collaborate effectively with internal and external key stakeholders.
- Ability to review, understand and explain the regulations and guidance documents to guide project teams.
- Proven success in communicating to and negotiating with FDA and global health authorities and managing clinical trial applications in several geographies around the world (for example US, Europe, Latin America, Asia).
- Ability to drive meetings with various stakeholders: (i) senior management, (ii) regulatory agencies (iii) investors, (iv) expert advisors v) collaborators and vi) project teams.
- Ability to comprehend and operate at high levels to address general issues and dig in deep to evaluate and address specific grass root issues
- Passion, self-starter, outcomes-oriented and innovative thinker.
- Outstanding written, oral, organizational, and interpersonal skills are required for this highly collaborative role.
Equal Employment Opportunity/M/F/disability/protected veteran status