Are you a seasoned Senior Regulatory Leader looking for a new and exciting challenge? Beacon Therapeutics (USA) Inc is seeking a talented individual to join us as a Full Time Senior Vice President, Head of Global Regulatory Affairs, completely remote! In this role, you will have the opportunity to l...
Principal Regulatory Affairs Specialist. Principal Regulatory Affairs Specialist to join our growing team. As a principal regulatory affairs specialist at BrioHealth Solutions Inc. Provide regulatory support for clinical and post-market activities including adverse event reporting, labeling updates ...
RBW is partnering with an innovative late clinical-stage, oncology Biotech (140 FTE) in their urgent and business-critical search for a new Senior Director, Regulatory Affairs. The client is seeking an autonomous, results-driven candidate who can lead cross-functionally, work well in a multicultural...
As the Senior Manager/Associate Director of Regulatory Strategy, you will play a critical role in driving the development and execution of regulatory strategies for our rare disease therapeutic programs. Your expertise and leadership will be instrumental in navigating the complex regulatory landscap...
A minimum of 10 years' experience in Pharmaceutical Regulatory Affairs/Regulatory Intelligence across major markets (Europe, North America, Asia Pacific) in Life Science industry and/or in consulting companies. We help companies advance their drug discovery, preclinical proof-of-concept, and regulat...
As the Regulatory Affairs Operations Specialist, Ad/Promo, you will play a pivotal role in ensuring regulatory compliance and operational efficiency within our organization. Strong understanding of Regulatory Operations processes and systems including Regulatory Information Management & Document/ Da...
Senior Regulatory Affairs Specialist. Responsible for managing product based regulatory activities of a medical device company that designs, manufactures, sells, and services medical imaging equipment. Manage preparation of regulatory documentation to facilitate the commercialization of new products...
They are seeking a Regulatory Affairs Manager (Contractor) who can provide day-to-day execution for regulatory submissions and compliance requirements. Reporting into the Senior Director of Regulatory and Clinical Operations, you will be responsible for the development and management of regulatory a...
Director of Pharmacovigilance & Regulatory Affairs. This VP will lead global regulatory function and develop regulatory strategy for new product development and registration as well as life cycle management. Prepares and reviews technical documentation in support of regulatory submissions and approv...
Collaborate with the leadership teamto develop Regulatory Strategy as part of an integrated development plan for each Corbus asset including inclusion/adoption of accelerated regulatory pathways where possible. As a pivotal member of the Corbus Product Development Team(s) (PDT) supports Corbus’ drug...
The Sr Director, Regulatory Affairs is accountable for developing regulatory strategies for norovirus vaccine candidates with an emphasis on European requirements for early and late stage assets. Provide critical regulatory input to cross functional internal teams, external CROs and consultants in t...
A minimum of 10 years’ experience in Pharmaceutical Regulatory Affairs/Regulatory Intelligence across major markets (Europe, North America, Asia Pacific) in Life Science industry and/or in consulting companies. We help companies advance their drug discovery, preclinical proof-of-concept, and regulat...
They are actively hiring a Senior Manager/Associate Director, Regulatory Affairs to act as the regulatory lead on multidisciplinary projects and clinical study teams, to provide input on documentation and procedural requirements defined by regulatory authorities. Senior Manager/Associate Director, R...
The Associate Director Regulatory Affairs - Oncology is responsible for the regulatory strategy development and execution for their assigned projects in the United States, and supporting other North American countries. Location:The Associate Director Regulatory Affairs location is flexible, includin...
The primary responsibilities of the position are to drive improvements in regulatory affairs processes, systems and infrastructure whilst supporting regulatory strategy and registration across global markets across the entire Regulatory Affairs group. Individuals will be expected to help drive regul...
The SVP, Global Regulatory Affairs is responsible for leading, managing, and driving all aspects of the Regulatory Affairs function, including leading the Global Regulatory Strategy team. This role partners with the Chief Regulatory Affairs Officer (CRAO) and Global Regulatory Program Leads to devel...
Are you a seasoned Senior Regulatory Leader looking for a new and exciting challenge? Beacon Therapeutics (USA) Inc is seeking a talented individual to join us as a Full Time Senior Vice President, Head of Global Regulatory Affairs, completely remote! In this role, you will have the opportunity to l...
The principal specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide. Maintain Regulatory affairs documentation to support compliance with applicable regulato...
Reporting to the Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling, the Associate Director/Director, Regulatory Affairs, Advertising and Promotion will be responsible for providing sound regulatory advice related to communication of information related to assigned Alkermes produ...
Keep abreast of regulatory procedures and changes to standards and Initiate research and regulatory intelligence in support of designated regulatory activities, as required, and provide information on regulatory requirements. Communicate/liaise with clients, regulatory agencies/competent authorities...
Regulatory Affairs professionals; provide invaluable strategic, technical, and regulatory advice to help clients with their various innovative product applications; and manage client relationships. Provide expertise in interactions with regulatory agencies (such as FDA) and provides expertise on reg...
Provides communications between Global Regulatory Affairs CMC and partners within GRA and across and outside of the organization, as evidenced by the successful achievement of CMC regulatory milestones according to project plans, and by the level of partner satisfaction with the support provided by ...
Manager, Global Regulatory Affairs CMC Submissions Management in Lexington, MA to establish global submission activities and timelines in partnership with global and cross-functional stakeholders in Pharmaceutical Science, GMS, Biologics and Small Molecule operating units, Regulatory Affairs, and QA...
The Fountain Group are a national staffing firm and are currently seeking a Regulatory Affairs Manager III for a prominent Pharmaceutical client of ours. This role is responsible for Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations, and p...
Sound interesting? Then come and join our global teamas Head of Clinical, Regulatory, and Quality to take on the role of strategic regulatory lead while ensuringquality system requirements are continuously improved. As the Head of Clinical and Regulatory Affairs, you will be responsible for:. Suppor...