Vice President, Regulatory Science Communications
About the Company
Accomplished biopharmaceutical company
Industry
Biotechnology
Type
Public Company
About the Role
The Company is seeking a Vice President for Regulatory Science Communications to lead a diverse and growing team in the preparation and submission of critical regulatory documents. The successful candidate will be responsible for the functional areas of scientific and regulatory writing, editing, and document quality control, ensuring the timely and high-quality delivery of documents across all stages of development. This role involves providing expert leadership, building and maintaining an effective team, and overseeing the development of standards, procedures, and processes for regulatory document development. The Vice President will also be involved in strategic planning, resource management, and continuous improvement initiatives. Key requirements for the role include a BS/BA, MS/MA, or PhD in a related discipline, with a minimum of 17 years of experience, and a preference for a PhD. The ideal candidate will have a strong background in regulatory requirements, industry practices, and experience in the preparation of complex documents for regulatory submissions, particularly IND, NDA/BLA/MAA. Certification in a relevant field is preferred, as is in-depth experience with electronic systems for submissions. The role demands a strategic and proactive approach, the ability to engage and influence stakeholders, and a proven track record of leadership and management in a regulatory or scientific environment.
Travel Percent
Less than 10%
Functions
...Call Center Representative - Onsite in Chicago Job Details Job Location Corporate Office - Chicago, IL Salary Range $17.7... ...skills Ability to work a flexible schedule, to possibly include nights/weekends/holidays as required Technical troubleshooting...
...Job Description Allied Universal, North Americas leading security and facility services company, offers rewarding careers that... ...depending on the position and eligibility. As a Security Guard - Unarmed Patrol - Driver in East Syracuse, NY , you will serve and...
...Job Description Job Description As an event security guard, it is your duty and responsibility to provide security, oversee and manage... ...such as two-way radios in a clear and concise manner No experience or license required Salary depends on experience from $13....
...Dental Hygienist - E. Norriton, Pennsylvania 1 WEEK PTO AFTER 90 DAYS! Plymouth Meeting Family Dental 350 E. Germantown Pike... ...50-52/hr Plymouth Meeting Family Dental is an established office in the community and is looking to add an additional Dental Hygienist...
...Title: Supervision Assistant/Health Office Assistant DBM Classification: B21/Class 4 | B22/Class 5 Department: Elementary Salary Range: $18.54 - $27.36 Employee Group: EM Spark Prepared Date: August 2025 Reports to: School Building...