Regulatory Affairs Specialist

Lancaster, NH

Posted: 03/05/2020 Job Number: JN -032020-11466

Job Description

SRG offers flexible staffing solutions with a national presence. We provide contract-to-hire, direct-hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

Position Title: Regulatory Affairs Specialist
Location: Northern New Hampshire
Industry: OTC Drug/Consumer Product Manufacturing
Salary: $80,000-$100,000
Employment Type: Direct Hire

Environment:
Join a global company that values its employees! YOU will have the opportunity to contribute to an environment that celebrates your unique talents, values your dedication, and allows your voice to be heard. This client manufactures and packages a wide variety of products for their customers, including OTC drugs, dietary supplements, homeopathics, cosmetics, animal feed supplements and dosage form animal health products in the formulations of liquids, creams, lotions, gels, and compressed tablets. This company has been committed to the highest standards of quality, customer service and value for over 150 years with a dedicated and experienced staff at all levels within the organization and excellent Quality Systems to ensure regulatory compliance and traceability.

Position Overview:
Oversees the regulatory process for products requiring government approval, including filing necessary applications and handling all government interactions. Ensures compliance with regulations and standard operating procedures (SOP) to minimize product liability and add business value.

Job Duties and Responsibilities:
  • Report information on regulatory trends and concerns to the leadership team.
  • Work closely with quality on regulatory responsibility.
  • Complete regulatory submissions to governmental agencies.
  • Advise on new product regulatory and compliance risk.
  • Integrate customer quality systems with company quality systems.
  • Host facility audits; serve as primary contact for auditors (regulatory body, 3rd party, customers, etc.).
  • Represent Regulatory Affairs on R&D product development.
  • Serve as Company representative with regulators, trade associations, corporate personnel, legal resources and external customers.
  • Review reports and documentation to assure compliance with regulations.
  • Support introductory and recurrent training for all company personnel in regulatory affairs.
  • Work as liaison with regulatory attorney for guidance to ensure compliance.
  • Complete customer questionnaires as they pertain to regulatory.
Requirements and Qualifications:
  • Strong interpersonal skills with the ability to influence others in a positive and effective manner.
  • Ability to work well in both an individual and group setting. Critical thinking using logic and reasoning to identify the strengths and weaknesses of alternative solutions to problems.
  • Experience working in an FDA regulated environment with strong knowledge of 2-CFR 210, 211, 111 required.
  • Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
  • Bachelor s degree with 2-5 years related experience and/or training, or equivalent combination of education and experience.
  • Experience within Pharmaceutical, Consumer Products, Food and Beverage, Nutraceuticals or related fields.
  • Experience working within a CMO, (Contract manufacturing Organization) is highly preferred.
EOE/ADA

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