Job Summary
The Director, Regulatory Affairs will oversee regulatory activities across Emergent's product portfolio. This position is responsible for providing strategic direction to the business and other stakeholder functions as it pertains to EU & global licensure of Emergent products.
Key Responsibilities
* Directs and develops a regulatory group located across Emergent sites or remotely located.
* Develops and leads regulatory strategy, for the EU and global, for Emergent products.
* Provides regulatory guidance to cross-functional groups regarding all aspects of manufacturing, quality, preclinical and clinical development and testing for products with a focus on EU and/or UK requirements.
* Directs efforts for planning and execution of required regulatory filings.
* Works with project teams to resolve complex project issues.
* Prepares company team for EMA or other health authority meetings.
* Serves as Regulatory Liaison to the EMA, MHRA, or local Member State Health Authorities in the EU (and other regulatory authorities) for assigned projects.
* Represents Regulatory Affairs at cross-functional teams core teams.
* Manages preparation and communicates regulatory risk assessment to core team, business unit team and senior management; proposes mitigation approaches.
* Provides critical review of documentation supporting regulatory applications including, but not limited to, pre-IMPD and formal meetings with health authorities, IMPDs, Clinical Trial Applications, Annual Reports, BLAs, NDAs, MAAs, Variations and BLA supplements.
* Ensures RA activities are aligned with Project timelines & business objectives and are in compliance with ICH, FDA, HC, UK, and EU regulations.
Requirements
* Bachelor's degree in related biological and life sciences field (Master's or Ph.D. preferred).
* 12+ years directly related experience in Regulatory Affairs, in biotechnology or pharmaceutical industry.
* Knowledge of EU and global regulations/guidance and thorough knowledge of biological/drug development process required.
* Strong strategic and critical thinking, diplomacy, negotiation and excellent oral and written communications skills.
* Strong decision-making abilities.
* Ability to understand and apply technical materials and regulations, strong technical writing skills, knowledge of CMC, clinical and non-clinical pharmaceutical development.
* Possess a broad knowledge of biopharmaceutical manufacturing and operations.
* Demonstrated people-leader skills and evaluation of performance.
About Us
Emergent BioSolutions is dedicated to protecting and enhancing 1 billion lives by 2030. We strive to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.
We believe in our values:
* Lead with Integrity: We gain trust and confidence through ethics, quality, and compliance excellence.
* Stand shoulder to shoulder no matter what: We combine our best thinking and communicate openly to support each other.
* Own it always: Every person at Emergent is engaged and accountable for delivering on our commitments.
* Break through thinking: We take smart risks, pursue innovation and challenge ourselves to constantly improve.
* Compete where it counts: We set the right goals and respect each other as we conquer them together.