What are the responsibilities and job description for the Senior Regulatory Operations Specialist position at Katalyst Healthcares & Life Sciences?
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 client's 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.
- 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 client's products and processes.
- With minimum guidance and supervision, support systems for product compliance and maintenance and support key user responsibilities as applicable.
- 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.
- 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 client's 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 BI, but able to drive change.
