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Regulatory Affairs Specialist

Remote:

Full Remote

Contract:

Full time

Experience:

Senior (5-10 years)

Work from:

New Jersey (USA), United States

Offer summary

Qualifications:

Bachelor's or Associate's degree in relevant field and 6-8 years industry experience, Knowledge of Regulatory Affairs, trends, legislation, and product maintenance requirements.

Key responsabilities:

Support data maintenance, regulatory submissions, and develop work processes
Stay updated on regulations, guidelines, and trends. Provide training and guidance to team members

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities:

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

Requirements:

Bachelor's degree, preferably in science, and 6 years relevant industry experience (OR)
Associate's degree and 8 years of relevant industry experience.
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 Regulations for streamlined processes.
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.