AD/Director, Global Regulatory Lead - FSP

Work Schedule

Environmental Conditions

Job Description

A day in the Life:

• Provide strategic operational and tactical regulatory insight on pre-approval and post-approval activities globally
• Support in identifying the organizations suitable filing approach and work together with various subject areas to achieve punctual filings.
• Oversee regulatory affairs vendors involved in marketing authorization filings and help ensure high quality interactions with regulators
• Working with the regulatory team provide hands-on contributions to regulatory filings including INDs BLAs and MAAs and other areas as requested
• Provide regulatory leadership with post-approval activities including application maintenance activities such as drug registration and listing payment of program user fees
• Monitor interpret and relay alterations within the global regulatory environment
• Act as the regulatory affairs business ally for local commercialization teams
• Partner with medical legal quality PV and distribution teams to ensure regulatory input is provided in a timely matter to support business decisions
• Act as the link between the strategy within the assigned project team and the wider global regulatory and development teams

Education:

• Preferred: PhD or PharmD or equivalent experience

Experience

• Requires a minimum of 10 years in regulatory affairs within biopharmaceutical companies including 5-7 years in global leadership roles focusing on key regulatory regions like FDA EMA or PMDA.
• Prior experience working in rapidly growing pharmaceutical organizations is desirable

In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills Abilities

• Proficient in orphan drug development knowledgeable about US regulations and evolving guidelines
• Demonstrated proficiency in orchestrating the production of vital regulatory documentation associated with the approval of medicines emphasizing the FDA
• Affinity with science and ability to interact with scientists and clinicians
• Experience interacting with regulatory authorities especially the FDA and EMA
• Familiarity with current and emerging regulatory legislation industry trends and health care business practices globally
• Well-developed organizational skills and project management abilities showcasing strengths in planning delegating tasks allocating resources and prioritizing workloads
• Track record of successful interactions with regulatory and health authorities
• Ability to work well in a fast-paced accountable environment
• Ability to collaborate & work cross functionally with various teams
• Proven Leadership skills with the ability to develop and lead teams
• Use critical thinking and implement strategies leading teams

Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued