Senior Specialist, US Regulatory Affairs Operations

3 weeks ago

Athens, United States Astrix Technology Full time

Senior Specialist, US Regulatory Affairs Operations

Clinical

Athens, GA, US

Pay Rate Low: 30 | Pay Rate High: 35

+ Added - 20/08/2024

Apply for Job

Great opportunity for a Part time Sr. Specialist to work for a global, research-driven pharmaceutical focusing on treatment options for diseases and conditions for which there is no satisfactory treatment option to date. This is an amazing opportunity to work on cutting edge treatments and make a difference.

**Senior Specialist Regulatory Affairs**

+ 20 hours per week (requied to be in the office 2-3 days per week)

+ 35.00 per hour

+ Anywhere between 8 am to 5 pm

+ Monday-Friday as scheduled and aligned with manager.

+ Location can be St. Joseph, MO or Athens, GA

**Job Description:**

+ Independently perform computerized system testing and proactively suggest improvements in systems and processes.

+ Ensure that all submissions are prepared per established requirements and submitted within established timelines.

+ Maintain working knowledge of regulations, policies, and guidelines with appropriate agencies.

+ Assist in preparing regulatory submissions for ctivities.

+ Maintains advanced and current knowledge of relevant regulations, policies, and guidelines and acts as Regulatory Affairs Subject Matter Expert in assigned areas.

+ Understand and monitor regulatory trends; understand and implement regulations and guidance.

Education:

+ Bachelor's degree, preferably in science, and 3 years relevant industry experience

**Skills**

+ Strong proficiency in supporting computerized system migration, testing, and implementation of new systems and system enhancements.

+ Strong experience creating detailed work instructions, training materials and communications.

+ Experience in organizing and facilitating cross-functional meetings and trainings.

+ Regulatory Affairs or equivalent industry experience is required - Intrapreneurial spirit while being rigorous and disciplined with compliance requirements.

+ Self-motivated with a high degree of initiative, commitment and persistence.

This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you

INDBH

#LI-DNP

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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