Executive Director & Vice President, Head of Regulatory Affairs
About the Company
Innovative biopharmaceutical company
Industry
Pharmaceuticals
Type
Public Company
Founded
1991
Employees
201-500
Categories
Business Classifications
About the Role
The Company is in search of an Executive Director/Vice President, Head of Regulatory Affairs to join their dynamic team. The successful candidate will be a key leader in the global strategy development and execution of regulatory affairs objectives. This pivotal role involves overseeing the design and execution of clinical trials, managing all regulatory submissions, and ensuring the company's regulatory goals align with industry standards. The ideal candidate will have a scientific background, with a Ph.D. or PharmD. preferred, and a proven track record in the pharmaceutical or biotech industry. Experience in FDA regulations, ICH guidelines, and a strong background in drug development processes are essential. Responsibilities for this position at the company include collaborating with cross-functional teams, providing regulatory expertise for product opportunities, and leading the regulatory affairs team. The role demands a strategic thinker with the ability to anticipate global regulatory changes and develop proactive strategies. The candidate should be results-driven, team-oriented, and have excellent communication skills to interact with both internal and external stakeholders. Experience in inhalation products and biologics, as well as post-approval change management and product life cycle management, is highly valued. The individual must be prepared to work in a fast-paced environment, exhibit a passion for patient care, and be willing to travel as needed.
Hiring Manager Title
Chief Medical Officer
Travel Percent
15%
Functions
...future. Siemens eMobility is shaping the electric mobility market with innovative... ...here! (We are looking for qualified engineering candidates for our eMobility Experience... ...for ambitious, curious, and adaptable entry-level talent. This program provides you with...
...expenses(ticket, travel) What: We are looking for reliable, enthusiastic people that can track events fromcollege / professional sports in real time, from thevenue(using our mobile application +any modern iOS or Android phone/tablet) Who: You must be at least...
Job Quick Facts: Specialty: Anesthesiology Job Type: Locum Tenens Facility Location: Gettysburg, PA Service Setting: Inpatient Reason For Coverage: Supplemental Coverage Period: Dec 1, 2024 - May 31, 2025 Coverage Type: Clinical + Call Shift/Call...
...competing with existing Jobseekers. For entry-level Job seekers to get client interviews and... ...are looking for Entry Level Java Cloud Developer (Remote)Who Should Apply Recent Computer... ...life cycle Knowledge of Statistics, SAS, Python, Computer Vision, and data visualization...
...inspection bonus Requirements: ~26 ' box truck ~ Truck no older than 2013 No SAP / DUI / moving violations Six months of verifiable OTR experience 120-minute onsite orientation in Chicago, IL . You pick up your first load the same day!...