Regulatory Affairs Ops Specialist II

6 month contract

$30-39 / hour

Description : M-F 8 - 5

M-F 8 - 5

Remote is an option but Onsite Preferred

Summary :

• Responsible for the implementation of complex global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of products.
• Serves as a consultant to managers. Manage regulatory activities relating to specific global portfolio of products / projects.

Qualifications :

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Knowledge of regulations
• Scientific knowledge
• Project management skills
• Manage multiple projects and deadlines
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Strong negotiation skills
• Technical system skills (e.g. word processing, spreadsheets, databases, online research)
• Ability to work effectively in multinational / multicultural environment
• Ability to identify compliance risks and escalate when necessary

Education and / or Experience :

• Bachelor’s degree or country equivalent in a scientific discipline
• Minimum of 5 years regulatory experience within a pharmaceutical company for medicinal products, CRO, or similar organization.
• FDA regulations and knowledge
5 hours ago