Job ID: 482
This position will oversee the development and implementation of sound regulatory strategies for multipleproducts including the preparation of submission-relevant documents relating to company’s development activities.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
• Develop and implement sound national and international regulatory strategies for multiple products.
• Plan, coordinate, and prepare for meetings and teleconferences with regulatory agencies.
• Write paper and electronic submissions, as applicable, to support development project plans and timelines for IND, NDA, and MAA and related submissions, as well as amendments and supplements to these applications and responses to regulatory agency requests.
• Collaborate with responsible departments and leads preparation, review, and collection of documentation for regulatory submissions.
• Provide critical review of all documentation supporting regulatory applications.
• Oversee the regulatory collaboration with CROs or other partnering organizations and coordinate international submissions to meet regulatory requirements.
• Work with peers to develop standard operating procedures and departmental guidelines.
• Participate as a full member of the research and development team(s) for the company’s products.
• Develop and manage regulatory project specific timelines, in keeping with Corporate objectives and actively participates on project teams advising on submission preparation timelines, processes, and requirements.
• Review and approve protocols, reports, and documents used in regulatory submissions.
• Mentor regulatory associates and managers.
• Assume other relevant assignments as directed by supervisor
• Bachelor’s degree in Biology or Chemistry, advanced degree preferred
• 10 years of industry knowledge experience
(pharma, biotech, CRO).
• 5 years of regulatory experience.
REQUIRED KNOWLEDGE AND ABILITIES:
• Strong verbal and written communication skills are essential.
• Excellent organization and multi-tasking skills.
• Exceptional interpersonal skills and problem solving capabilities.
• Proven negotiation skills.
• Ability to work effectively across a matrix organization.
• Ability to work independently and prioritize with minimal daily instruction.
• Ability to think strategically in order to improve current processes