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US Regulatory Affairs Operations Senior Specialist

2 months ago

Athens, United States JobsRUs.com Full time
JobsRUs.com
is seeking to hire a Senior Specialist for our client in Athens,GA

Pay $37.00/Hour

Anywhere between 8 am to 5 pm, Monday-Friday as scheduled and aligned with manager
20 hours per week
Note requirement to be in the office 2-3 days a week.

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 activities
Contribute to the development and implementation of applicable work processes and instructions
Ensure they are kept up to date and implemented.

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
Interact with the authorities in a professional manner
Interfaces with relevant stakeholder groups as needed to ensure compliance
Provide training for team members in assigned areas of responsibility
Provides guidance/direction within the regulatory department and stakeholder groups relative to regulatory compliance of BIAH products and processes.

With minimum guidance and supervision, support systems for product compliance and maintenance and support key user responsibilities as applicable.

Knowledge in relevant Regulatory Affairs areas
Ability to understand and anticipate regulatory trends.

Knowledge and established understanding of regulatory legislation and requirements for the maintenance of veterinary products

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.

-Demonstrated ability to successfully collaborate in a global organization and manage a full workload.

- Effective communicator with good negotiation and interpersonal skills and the ability to form productive working relationships at all levels across disciplines and nationalities.

- Strong attention to detail

- Must exhibit good judgment, and ability to problem-solve issues in daily work

- Able to meet stringent time and quality demands.

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

- Well developed organizational capabilities.

- Strong team player who is collaborative with the mission of BI, but able to drive change.

- AAI Competencies

Accountability: Taking ownership for decisions and actions.

Agility: Quickly acting with an open mind to face internal and external circumstances
Intrapreneurship: Together with our customers, internal or external, creating innovative ideas to respond to changing needs.

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

OR

Associate's degree and 5 years of relevant industry experience

OR

In lieu of degree, 8 years of relevant industry experience including 3 years related regulatory experience.