We currently seek a high caliber regulatory affairs manager within our client's team of experienced professionals. This position is located in Glendora, CA
M.S. in Regulatory Science or a related technical field preferred.
Minimum 10 years knowledge and experience in Regulatory Affairs in the manufacture and distribution of pharmaceutical products and sterile, disposable medical devices.
Thorough understanding of FDA QSR (21 CRF 820), medical device manufacturing and ISO/EC (MDD, CMDR, ISO 13485) requirements.
Thorough understanding of the CFR, FDA/ICH guidelines and cGMP's, as they pertain to pharmaceuticals.
Knowledge of pharmaceutical industry regulatory affairs throughout the product lifecycle, with awareness of preclinical, clinical, commercialization, and operations.
Capability to respond to changes in the regulatory environment and make strategic recommendations to minimize risk to the business.
Ability to interpret Regulatory Authority policies, guidance and correctly apply them as appropriate in product development.
Ability to take innovative ideas from proof of concept to promote a successful product regulatory submission and increase probability of regulatory approval.
Ability to review detailed scientific information and assess whether technical justifications are presented clearly and conclusions are adequately supported by data.
Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks.
Formulate and lead regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.
Proactively communicate regulatory strategies, key issues and any other critical topics throughout the life cycle.
Lead submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
Make quality regulatory decisions, balancing risks and benefits.
Identify and prepare regulatory submissions for approval (i.e. 510k).
Act as company management representative during on site Quality System audits by regulatory agencies and customers.
Maintain Establishment Registrations, Device Listings and State Licenses both Domestic and International.
Generate annual medical device management review and drug annual reports.
Ensure the appropriateness of regulatory standards referenced within Quality System, maintain updated standard library and conduct GAP/risk analysis to determine impact of standard changes/revisions.
Review and approve domestic and international product labeling, promotional materials, product packaging, and advertising copy. Conduct regulatory assessments for changes to marketed products.
Review quality documents (operational procedures, work instructions, validations, etc.) including but not limited to protocols, for appropriate scientific rationale and for adherence to regulatory requirements/guidance, development
Other responsibilities as assigned
If interested, please contact Ann Pringle 949-349-4922 or email@example.com
TRS Staffing Solutions is an Equal Opportunity Employer that recognizes the value of a diverse workforce. Employment decisions are based on job related criteria and not on the basis of any unlawful criteria. We ensure equal access to employment opportunities, services, and programs.
Must have legal right to work in the United States. We thank all applicants for their interest; however, only those selected for interviews will be contacted.