Senior Specialist, US Regulatory Affairs Operations
4 weeks ago
Req Number: 33705637
Req Title: Senior Specialist, US Regulatory Affairs Operations
Client: A major pharma company
Work Address: 1730 Olympic Dr, 30601, Athens, GA
Duration: 18 Months with possible extension
Hours per Week: 40.0
(Location: St. Joseph, MO or Athens, GA (Note requirement to be in the office 2-3 days a week.)
Position Summary:
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 Client 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 Client's 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 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 Client, 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.
Qualifications:
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.
Required Skills:
CLINICAL REGULATORY
NewAge Clinical is a Division of NewAgeSys Inc., a Favored Provider to the major Drug/Biotech/Medical Devices Organizations in the USA offering broadened types of assistance to our clients, similar to medical care staffing administrations, clinical staffing, and R & D contract jobs. Established in 1994, NewAgeSys has exhibited phenomenal development winning lofty honors for being one of the quickest-developing organizations in New Jersey. We are an inventive association with a forceful business procedure, supplementing amount with quality and using a clever interaction that conveys a full help arrangement. With regards to medical care staffing administrations, clinical staffing, R and D contract jobs, and staffing administrations in New Jersey, NewAge Clinical stands separated concerning quality, when contrasted with others. We understand that the process of selecting a consultant for a clinical trial or pre-clinical project often takes some time. We regard the time that this cycle takes by guaranteeing a completely thorough screening interaction to guarantee shared accomplishment to assure mutual success for our candidate's and client's proficient staffing needs.Company DescriptionWe Are Standing With 30+ Years Of Experience.\r
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NewAge Clinical is a Division of NewAgeSys Inc., a Favored Provider to the major Drug/Biotech/Medical Devices Organizations in the USA offering broadened types of assistance to our clients, similar to medical care staffing administrations, clinical staffing, and R & D contract jobs. Established in 1994, NewAgeSys has exhibited phenomenal development winning lofty honors for being one of the quickest-developing organizations in New Jersey. We are an inventive association with a forceful business procedure, supplementing amount with quality and using a clever interaction that conveys a full help arrangement. With regards to medical care staffing administrations, clinical staffing, R and D contract jobs, and staffing administrations in New Jersey, NewAge Clinical stands separated concerning quality, when contrasted with others. We understand that the process of selecting a consultant for a clinical trial or pre-clinical project often takes some time. We regard the time that this cycle takes by guaranteeing a completely thorough screening interaction to guarantee shared accomplishment to assure mutual success for our candidate's and client's proficient staffing needs.
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