Regulatory Affairs Specialist

Swiss American CDMO Carrollton, Texas
regulatory regulatory compliance regulatory compliance insurance technical representative education manufacturing cmc production regulations management
December 4, 2022
Swiss American CDMO
Carrollton, Texas
FULL_TIME

Job Title:

Regulatory Affairs Specialist

Department:

Quality

Reports To:

Vice President of Quality, Regulatory, and Compliance

FLSA Status:

Exempt

Position Summary: The Regulatory Affairs Specialist will support regulatory activities related to Chemistry and Manufacturing (CMC) and SA Facilities changes across all Business Units and report to the Vice President of Quality, Regulatory, and Compliance. They will provide regulatory support for SA’s Contract Development and Manufacturing Operation (CDMO) sites. Responsible for supporting pre-production regulatory activities and ensuring completion of all post-production regulatory compliance.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Review and assess changes to global regulatory requirements and industry best practices and facilitate implementation through new or revised Quality systems processes
  • Guide cross-functional teams regarding regulatory risks and implications for strategy, product/process development, and/or post-approval change activities, and utilize technical knowledge and effectively apply regulations and guidelines to the assigned projects;
  • Responsible for working with other employees to resolve compliance issues as appropriate.
  • Responsible for coordinating regulation compliance for multiple countries.
  • Review and approve product labeling, advertising/promotional materials, etc. to assess regulatory implications.
  • Will participate in reviewing key FDA submission reports.
  • Responsible for site post-market surveillance activities
  • Responsible for Annual Review of Drug Products;
  • Responsible for Design File Management/Maintenance;
  • Responsible for site pharmacovigilance
  • Support clients with required documents for CMC (or similar) sections of regulatory submissions
  • Participate in multidisciplinary project teams with the Client
  • Responsible for regulatory input into change controls and CAPA with a limited scope to regulatory issues
  • Responsible for support, from a regulatory perspective, for external and internal audits;
  • Assists in developing procedures to ensure regulatory compliance.
  • Create or maintain technical files as necessary to obtain and sustain product approval.
  • Assist in data analysis and preparation of Management Review reports.
  • Attends and participates in meetings as required.
  • Maintains profession growth and development through seminars, workshops and profession affiliations to keep abreast of latest trends in industry.
  • Attention to detail is critical.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience:

Four year college or university program certificate; or three to five years related experience and/or training; or equivalent combination of education and experience.

Language Ability:

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format.

Math Ability:

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability:

Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.

Computer Skills:

To perform this job successfully, an individual should have knowledge of Microsoft Office Business Suite and Internet software.

Certificates and Licenses:

No certifications needed

Supervisory Responsibilities:

There are no supervisory responsibilities for the position.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate.

Physical Demands:

The physical demands 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.

There are no physical demands for the position.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.

Job Type: Full-time

Pay: From $69,000.00 per year

Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance

Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday

Ability to commute/relocate:

  • Carrollton, TX 75006: Reliably commute or planning to relocate before starting work (Preferred)

Education:

  • Bachelor's (Preferred)

Experience:

  • FDA regulations: 1 year (Preferred)

Work Location: One location


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