• Avantor
  • Coraopolis , PA
  • Healthcare - Allied Health
  • Full-Time
  • 112 Nyetimber Pkwy

Job Summary

The Sr Regulatory Specialist ensures VWR s Federal and State compliance related to the storage, sale and distribution of FDA related materials, includes but is not limited to, medical devices and pharmaceuticals for the Americas (US & Latin America). In addition, this position acts as the key interface for the Corporate Regulatory Affairs Organization to provide FDA and other related agency regulatory guidance and regulation interpretations that impact the Americas business. Keeps informed of regulatory regulations & changes and implement the necessary changes to maintain company compliance.

MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)

  • Keeps current on FDA & state pharmacy regulations and evaluates their impacts on VWR International s business, propose guidance, procedure implementation, programs & policies.
  • Responsible for maintaining VWR s compliance for sale, storage, and distribution of regulated products (includes pedigree requirements).
  • Coordinates & participate in agency inspections/audits and responds to applicable agency requests.
  • Assists sales team and customers with questions pertaining to regulation requirements.
  • Responsible for the development & maintenance of related SOPs.
  • Prepares and presents training material to VWR associates.
  • Maintains applicable master data coding for regulated products.
  • Applies for and renews federal and state licenses, including Board of Pharmacy requirements.
  • Responsible for product reviews & classification accuracy.
  • Performs other duties as assigned.
  • QUALIFICATIONS (Education/Training, Experience and Certifications)

  • Bachelor s degree, preferably in a science related field
  • 5-8+ years regulatory experience in medical device or pharmaceutical industry
  • DEA knowledge and clinical experience a plus
  • KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)

  • Demonstrates a thorough knowledge of FDA regulations, ICH Guidelines, Drug Quality and Security Act, Pedigree, Adverse Event Reporting, cGMP, GDP and Sunshine Act
  • Board of Pharmacy (BOP) and Verified- Accredited Wholesale Distributor (VAWD) knowledge
  • Strong interpersonal skills, required to talk to customers, suppliers and VWR associates
  • Good analytical and problem solving skills.
  • Good organizational skills
  • Strong computer skills including Word, Excel and Access
  • SAP knowledge a plus
  • ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)

    Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level.

    Travel up to 10% of time.

    Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.

    A frequent volume of work and deadlines impose strain on routine basis.

    Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.

    DISCLAIMER:
    The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
    Avantor is proud to be an equal opportunity employer.

    EEO Statement

    We are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state, or local law.

    If you need a reasonable accommodation for any part of the employment process, please contact us by email at ...@avantorinc.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

    For more information about our commitment to equal employment opportunity, please Privacy Policy (Links to (1) EEO is the Law poster and any supplements, (2) pay transparency nondiscrimination statement, and (3) if desired, Company EEO/AA Statement


    Associated topics: laboratory, medical laboratory science, microbiology, mls, scientist, sterile processing technician, technician ii, technician iii, technician laboratory, technologist

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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