Regulatory Affairs - Packaging & Labelling - Umanist Staffing LLC

Overview:

The role of a Regulatory Affairs - Packaging Labeling professional is crucial within the organization as they are responsible for ensuring that all packaging and labeling materials comply with regulatory standards. They play a vital role in ensuring the safety, efficacy, and quality of products by navigating complex and ever-changing regulatory requirements.

Key Responsibilities:

Develop and implement strategies for packaging and labeling compliance.

Review and approve packaging and labeling materials for regulatory compliance.

Ensure adherence to all relevant regulations and standards for packaging and labeling.

Manage and maintain regulatory documentation related to packaging and labeling.

Provide regulatory support for new product development and launches.

Coordinate with cross-functional teams to ensure regulatory requirements are met.

Stay updated on changes in regulations and communicate implications to stakeholders.

Prepare and submit regulatory filings related to packaging and labeling.

Conduct risk assessments related to packaging and labeling changes.

Participate in regulatory agency inspections and audits.

Collaborate with internal and external partners to resolve regulatory issues.

Contribute to the development of regulatory strategies and policies related to packaging and labeling.

Support post-market surveillance activities related to packaging and labeling.

Provide regulatory intelligence and guidance to internal teams.

Required Qualifications:

Bachelor's degree in a relevant field such as Regulatory Affairs, Chemistry, Pharmacy, or related discipline.

3+ years of experience in regulatory affairs with a focus on packaging and labeling.

Demonstrated understanding of global regulatory requirements for packaging and labeling.

Strong knowledge of quality management systems and Good Manufacturing Practices (GMP).

Experience in preparing and submitting regulatory filings.

Excellent analytical and problem-solving skills with attention to detail.

Ability to interpret and apply regulatory requirements to packaging and labeling materials.

Effective communication and interpersonal skills for collaboration with internal and external stakeholders.

Capability to prioritize and manage multiple projects simultaneously.

Proficiency in using regulatory databases and software.

Understanding of packaging and labeling processes within the pharmaceutical or medical device industry.

Knowledge of labeling requirements for different global markets.

Ability to work effectively in a fast-paced and dynamic environment.

Certification in Regulatory Affairs or related field is a plus.

Strong ethical conduct and commitment to compliance.