Current Open Jobs & Employment Oppportunities | Insperity

Manager, Regulatory Affairs

Job Title
Manager, Regulatory Affairs
Job ID
27429875
Location
CARROLLTON,  TX 75006-6623
Other Location
Description

Swiss American CDMO LLC is a topical drug, skincare, wound care, and medical device developing and manufacturing company founded to provide cutting-edge topical skincare technologies to selected markets. Our business strategy consists of development, manufacturing, and superior customer service to contract manufacturing customers worldwide. A strong team approach to serve our customers is the basis of our mantra – “Partnering to deliver service through quality, integrity, and commitment.” Are you passionate about Service Excellence, Results, Integrity, and Leadership? These are the core attributes we are looking for at Swiss-American CDMO, LLC. To see all of the opportunities currently available with Swiss-American CDMO, please follow this link in addition to exploring the opportunity that you have already selected below - www.swissamericancdmo.com/careers.

Manager, Regulatory Affairs

The Manager, Regulatory Affairs (RA) & Compliance will support regulatory activities related to Chemistry and Manufacturing (CMC) and SA Facilities changes across all Business Units and report to the Director, Quality, Regulatory & Compliance. They will provide regulatory support for SA’s Contract Development and Manufacturing Operation (CDMO) sites. The Manager will support the development of sound regulatory strategies and follow-through to implementation to assigned project teams for CMC and facilities topics. As the senior-most regulatory affairs personnel in the organization, this role is responsible for providing leadership, supporting pre-production regulatory activities, and ensuring completion of all post-production regulatory compliance.  Time is split between moderate to high-risk regulatory projects and the management of a small team of regulatory and compliance specialists and associates.

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

  • Work with other RA, Quality, Product Safety (PS), or Research, Innovation & Development (RID) team members and product leads to ensure best outcomes for CMC changes
  • Review and assess changes to global regulatory requirements and industry best practices and facilitate implementation through new or revised Quality systems processes
  • Guide 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 managing regulatory and compliance intelligence, policies, and programs of diverse scope across the business
  • Responsible for working with other employees to ensure adherence to compliance of products, resolve compliance issues, as appropriate, and communicate as required to clients
  • Responsible for site post-market surveillance activities
  • Trains, supervises, motivates, and develops team
  • Manages schedules and workflow of a team of 3-6
  • Responsible for Annual Review of Drug Products
  • Responsible for Design File Management/Maintenance
  • Responsible for review of customer-created labeling for appropriate claims
  • Responsible for site pharmacovigilance
  • Responsible for coordinating regulation compliance for multiple countries
  • Will participate in reviewing key FDA and other countries submission reports
  • Assists in developing procedures to ensure regulatory compliance
  • Oversee the creation and/or maintenance of technical files as necessary to obtain and sustain product approval
  • Support clients with required documents for CMC (or similar) sections of regulatory submissions
  • Serve as an internal resource for assembly and authoring of 510k files
  • Determine and communicate submission and approval requirements early in the product lifecycle to assure that project plans are aligned with submission strategies and regulatory guidelines
  • Write regulatory documents for submission to FDA and any other regulatory agencies, as needed
  • Under the direction of the Director of Quality, Regulatory & Compliance, handle the preparation of submission packages for regulatory agencies in compliance with applicable requirements and best practices
  • Identify issues early in the submission preparation process that could impact timelines/risks;
  • Participate in multidisciplinary project teams with the Client
  • Assist the Director of Quality, Regulatory & Compliance with the company's progress into commercial readiness efforts
  • Maintain knowledge base of existing and emerging regulations, standards, or guidance documents that could impact Swiss American's contract manufacturing strategies
  • Assist with training staff on regulatory requirements for submission across regulatory paths and agency interactions
  • Maintain Regulatory Intelligence tracker and supporting documentation repository
  • Partner with the Quality Systems and Operations groups to establish and confirm compliance metrics for Quality Management Reviews
  • Partner with the Quality and Operations groups to identify compliance metrics and trends that will feed governance reports
  • 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
  • Perform those duties, as assigned by the manager
  • Facilitate compliance with external experts when required

Supervisory Responsibilities:

  • Responsible for supervising a team of 3-6 personnel.

Qualifications:

To perform this job successfully, the ideal candidate must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Abilities, Knowledge, and Skills:

  • Attention to detail is critical
  • GxP expertise is required
  • Experienced in leading cross-functional interactions related to regulatory matters
  • Exercises judgment within generally defined regulatory practices and policies
  • Must be flexible and able to adapt to change
  • Is able to direct work as required and manage complexity
  • Must be a team player
  • Ability to work on problems of diverse scope
  • Must have a focus on professional development for self and team
  • Disciplined, detail-orientated, and excels in project management
  • Effective verbal and written communication skills required
  • Ability to partner with business peers and senior leaders
  • Proficient knowledge of the pharmaceutical and medical device R&D, product development, regulatory and quality environments
  • Deep knowledge of applicable global regulatory requirements
  • Experience with process management and continuous improvement
  • Ability to manage multiple priorities with aggressive timelines and key issues in complex situations and solves with minimal assistance
  • Excellent analytical skills required
  • Knowledge and experience of the development of one or more types of Health Authority regulated products (drugs, biologics, medical devices, combination products)

Education/Experience:

  • Bachelor’s Degree in a life science or related discipline is required. An advanced degree is preferred
  • Experience in pharmaceutical development with a history in process development/validation preferred
  • Minimum 8+ years of relevant pharmaceutical or biotechnology industry experience, with a minimum of 6 years in a quality/regulatory function. Less experience acceptable for suitable candidates with relevant industry experience and skillsets
  • Minimum 3 years of supervisory experience
  • Must have experience interacting with the FDA, EMA, Health Canada, and/or other agencies, as required

Computer Skills:

  • Knowledge of Microsoft Office Business Suite and Internet software

Certificates and Licenses:

  • RAC preferred

Benefits:

We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive annual salary, an extensive benefits package including paid time off, medical, dental, and vision benefits, 401K plan with company match, and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning, and culture.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.