Tosoh Bioscience LLC is a major supplier of chromatography products to the pharmaceutical, biotechnology, and chemical industries. Our product line includes:TSKgel, TOYOPEARL, and Ca++Pure-HA bulk media, TSKgel U/HPLC columns, process development products, dedicated systems for GPC analysis, and the LenS3 MALS detector. We have optimal solutions for biological research, drug discovery, medicinal chemistry, agriculture, manufacturing, or other industrial applications.
The salary range for this position has been established at $70,000 - $85,000. The salary of the candidate selected will be set based on a variety of factors, including but not limited to experience, location, education, specialty, and training. The above salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting. The Company offers a comprehensive package of compensation and benefits, including bonus plan in addition to base salary, medical, dental, vision and life insurance, 401(k) with Company match, four weeks paid time off per year for new employees in addition to company paid holidays, tuition reimbursement and opportunities for promotion and career development.
Summary
The Regulatory Support Specialist plays a key role in developing and driving the Regulatory Support department’s initiatives for high profile projects for products used in a GMP manufacturing environment.
Reporting Relationships
Reports to the Regulatory Support Manager. This position has no supervisory responsibilities.
Major Duties and Responsibilities
Participate in product-level regulatory initiatives aligned with customer requirements, industry standards, and business unit growth objectives.
Develop, implement, maintain, and update regulatory support materials for new and legacy products.
Collaborate with relevant departments to create and update guidelines and requirements for New Product Introduction process.
Escalate potential risks to management during planning, review, and data validation processes.
Improve internal regulatory support materials based on management goals.
Support and coordinate responses to regulatory requests from customers and other Tosoh Bioscience subsidiaries.
Build and maintain knowledge and understanding of customers’ regulatory requirements and expectations.
Participate in customer audits.
Remain current with regulatory intelligence related to the industry and ensure the alignment of Company’s documentation and regulatory support materials with the current standards/expectations.
Participate in any recalls, complaints, and regulatory reporting.
Participate in training for other departments and managers to raise awareness on regulatory, compliance, and qualification topics.
Maintain regular and reliable attendance.
Uphold and adhere to the Tosoh Bioscience culture and guiding principles.
Other related duties as assigned.
Education
Bachelor of Science degree in engineering, biotech, or related field. Other degrees can be considered based on experience.
Skills and Qualifications
3+ years of Quality Assurance/Compliance or Regulatory Affairs experience in biopharmaceutical industry
Knowledge and/or experience with cGMP manufacturing environment
Knowledge and/or experience with 21 CFR Part 11 compliance
Understanding of ISO 9001
Excellent oral and written communication, interpersonal and organizational skills, and attention to detail
Ability to interact effectively with management and prioritize multiple projects
Ability to embrace change and multi-task in a fast-paced environment
Technical proficiency, effective problem solving and critical thinking skills
Ability to consistently deliver under tight timelines and deadlines
Ability to work in a team environment
Ability to travel up to 25% of time.
Physical Requirements
The physical demands of this job are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. This is a primarily sedentary job that requires the ability to move to and from the desk and occasionally lift and/or move objects. Some travel required, up to 12 weeks per year.
Tosoh Bioscience LLC is an Equal Opportunity Employer M/F/Disabled/Veterans
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