Regulatory Compliance Specialist

1 week ago

Durham, North Carolina, United States Alcami Corporation Full time
Job Summary

The Senior Regulatory Compliance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, maintaining quality databases, developing and maintaining regulatory submissions (US, EU, ROW) for Alcami Corporation and external customers. The ideal candidate will assist with the development of Standard Operating Procedures (SOPs) or other quality and regulatory documents as needed. You will act as a consultant with clients for regulatory issues. The Senior Regulatory Compliance Specialist will provide guidance and mentoring for other Regulatory Compliance employees.

Responsibilities
  • Develops and Maintains Regulatory Submissions
  • Performs submission compilation, publishing, and electronic submission to health authorities.
  • Serves as an effective member of the Regulatory team and may serve as a mentor to other Regulatory employees in their area of expertise.
  • Performs quality review and approval of documents, data, protocols, and/or reports.
  • Review, negotiate (as needed) and approve Quality Agreements on behalf of the Company.
  • Participate in active drafting, review, and approval of Annual Product Quality Review reports generated by the Company to support Annual Reports filed by the application holder.
  • Support assessment of state licensing requirements as it pertains to activities performed by the Company and assist in managing documentation retrieval and submission to obtain such licenses when required by the respective state regulations.
  • Consults with clients on regulatory issues.
  • Maintains quality databases.
  • Assists with the implementation and supports quality systems, including but not limited to vendor management, training, internal audit program, and overall regulatory inspectional readiness initiatives.
  • Assists with quality improvement initiatives as needed.
  • Assists with development of SOPs or other quality documents as needed.
  • Maintains accurate files and records.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
  • Complies with company policies and SOPs.
  • Other duties as assigned.
Qualifications
  • Bachelor's degree in Chemistry, Biology, or related field with 10 years of GMP related experience, or Master's degree in related field with 5 years of related experience, or equivalent educational and work experience.
Knowledge, Skills, and Abilities
  • Consistently demonstrates honesty and integrity through personal example.
  • Follows all safety policies and leads by example a safety-first culture.
  • Produces high-quality work product with a focus on first-time right.
  • Complies with the company code of conduct and policies and regulatory standards.
  • Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
  • Demonstrated experience in developing and maintaining regulatory submissions (including publishing) for drugs, devices, or combination products in the US and international markets.
  • Good written and oral communication skills.
  • Good math skills.
  • Good computer skills and knowledge of Microsoft Office products.
  • Ability to be trained and to mentor.
  • Ability to interact well with clients and regulatory agents.
  • Ability to interact well with employees at all levels.
  • Ability to negotiate.
  • Ability to lead audits.
  • Ability to act as a consultant.
  • Uses professional concepts and company policies and SOPs to solve a variety of problems.
  • Receives minimal instruction on day-to-day work, general instructions on new assignments.
  • Demonstrated knowledge for providing effective strategies for submission approaches.
  • Demonstrated knowledge and experience for effectively providing guidance and mentoring across multiple markets for a Regulatory Compliance team and other employees.
  • Demonstrated knowledge and experience in preparing and reviewing Annual Product Quality Review reports.
Travel Expectations
  • Up to 5% travel required.
Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk, and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision. While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places, and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab or manufacturing areas for inspections or work discussions. The noise level in these additional work areas may be louder. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

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