Senior Specialist, US Regulatory Affairs Operations (Hybrid)

Job Title: Senior Specialist, US Regulatory Affairs Operations (Hybrid)
Location: St. Joseph, MO 64506 or Athens, GA 30601
Duration: 18 Months
Shift: Monday-Friday 8 am to 5 pm
Note the requirement to be in the office 2-3 days a week.
 
Duties:

• Independently support data maintenance and archival and retrieval of regulatory documentation in computerized systems.
• Assist with preparing high-quality US regulatory submissions required by local and federal agencies for the company products.
• 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.
• 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. 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 the Company products and processes.
• With minimum guidance and supervision, support systems for product compliance and maintenance and support key user responsibilities as applicable.

 
Skills:   

• 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.
• Strong proficiency in supporting data maintenance and archival and retrieval of regulatory documentation in computerized systems.
• Strong experience creating detailed work instructions that align with Regulatory Authority and Boehringer Corporate Regulations for streamlined processes.
• 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 the Company, 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.

 

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
 
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
 
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer. 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $35.00/hr.