Senior Regulatory Affairs Strategist

Location: United States – Homebased

Schedule: Permanent- FTE

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance with a quality-focused collaborative “one-team” culture. We are looking for a dynamic person to join our in-house team as a Director Pharmacovigilance (PV) Clinical Trials Operations on a permanent basis while working on projects from our varied client base ranging from small to big pharmaceutical biotechnology medical device and consumer health companies.

Join our team: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career!

Main Job Tasks and Responsibilities:

Primary Responsibilities: •    Responsible for the coordination of regulatory compliance functions starting at drug development stage and reaching through the lifespan of the product.  •    Activities required to set up and maintain the new drug label and essential product information (known as drug listing data) to Pfizer's website and FDA the National Library of Medicine (Daily Med) Website and the Drug Registration and Listing System team.  •    Drug listing activities for the approved products and other product licensing support activities to maintain compliance.  •    Compliance activities continue with coordination of information in support of New Drug Application BLA Annual Reports and NDA Periodic Reports.  •    Actively participate in driving solutions through partnership with internal and external colleagues to ensuring compliance and alignment with business process priorities and requirements •    Actively participate in cross-functional teams as appropriate •    Knowledge share and educate personnel as appropriate on internal processes agency requirements and guidelines. •    Development and maintenance of documented procedures and guidelines as necessary

Qualifications:

•    Bachelor’s or master’s degree in science or related discipline (or equivalent experience) •    5+ years relevant experience  •    Regulatory experience within the pharmaceutical industry or other relevant experience •    Self-starter with an ability to work in a team environment with minimal supervision. •    Strong communication skills as well as strong meeting presence •    Use diverse experience to meet deadlines and be detail orientated. •    Strong critical thinking and analytical skills required.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical biotechnology medical device and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4000 professionals in more than 20 countries across the Americas Europe and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.  The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting developing and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender race beliefs and ethnicities. We recognize this is our strength and celebrate it.

Key words : Regulatory Affairs Compliance drug label drug listing pharma FDA

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