Senior Manager/Associate Director Global Regulatory Affairs
My client is growing company with a collaborative dynamic committed to leveraging their understanding of innovative therapy surrounding cardio-metabolic drug development. Their passion is driven by the unmet needs of their patients as well as the science. They are currently seeking a qualified Manager who is internally motivated and can work in an environment where communication is key. In this exciting new role, the Manager will be managing several programs in various stages of development.
Responsibilities
- Leads and develops regulatory strategy submissions (including IND’s and marketing applications) that is reflective of applicable US, EU and other regional requirements acceptable for submission to global regulatory competent authorities (i.e. FDA, EMA), generates strategies, assesses risks and develops contingency plans.
- Experience leading or supporting regulatory interactions in a global arena (especially US).
- Acts as a regulatory representative to support cross functional team; accountable for assigned projects and activities, independently completing work within assigned work group/project teams, for multiple projects.
- Interprets regulatory requirements, develop strategies (including novel approaches), assess risks and develops contingencies.
- Accountable for assigned programs, managing day-to-day delivery of plans/submissions and strategic activities for specific assigned projects.
- Ability to operate independently, virtually, and as a leader to resolve complex issues and manage regulatory risks and ambiguous situations within project teams with support from line management.
- Responsible for the development and preparation of regulatory documentation, may act as a primary writer/editor or coordinator, coordination and management of global submissions (including but not limited to IND’s, IMPD’s, NDAs, MAAs, Response to Questions, Expedited Program Applications, Orphan Applications, etc.).
- Ability to collaborate effectively across a network of stakeholders, partners, customers contract research organizations (CRO’s) to deliver high quality submissions.
Knowledge and Skills
- Bachelor’s degree in scientific discipline; advanced degree preferred.
- At least 5+ years of previous industry experience in a strategic regulatory role.
- Regulatory Submissions, preparation and strategy in the US with diverse experience in leading and developing the strategy for multiple submission types including large submissions with intimate knowledge of the electronic Common Technical Document (i.e. IND’s, NDA’s).
- Strong Regulatory writer and reviewer for key documents such as response to questions, meeting requests, briefing documents, Module 2, Module 1 documents.
- Familiarity with regulatory operations, publishing and submissions preferred;
- Recent experience with the development and therapeutic areas of lipid drugs in the a US is a major plus. Excellent written and verbal communication skills (native and non-native English speakers) with the ability to meet regulatory requirements; develop strategies while maintaining effective relationships.
- Ability to lead, drive, communicate effectively, establish and maintain productive working relationships, and influence peers and others within the organization.
- Strong organizational skills and high level of attention to detail, with the ability to coordinate multiple large and diverse projects simultaneously. Ability to be highly driven and self-sufficient.
- Ability to wear multiple hats and work in a small company and virtual company fast-paced environment.
- High integrity with respect to maintenance of proprietary, confidential information.
- Strong decision-making and problem-solving skills.
- Composure under pressure