Senior Regulatory Affairs Associate

Description:

Oversee regulatory support and compliance in accordance with guidelines from USDA, FDA, and international regulatory agencies. Responsibilities will be related to new product development and the management of controlled documents.

• Communicate with government agencies (such as USDA and FDA) and current or potential business partners regarding regulatory matters.

• Provide necessary documentation to distribution partners and international government agencies for product registration or maintenance of registration.

• Support the process of new product licensing.

• Apply for or renew permits to receive or regulated materials.

• Apply for or renew permits for international exportation of products.

• Collaborate with various departments to plan, organize, conduct, and monitor clinical trials and testing.

• Develop protocols and prepare final reports for clinical trials.

• Review, update and draft new Standard Operating Procedures (SOPs) within the Regulatory Affairs Department as needed.

• Review and prepare outlines of production and special outlines.

• Develop and revise ASR/Sampling Plans for raw materials, in-process products, and stability programs.

• Work with departments to determine specific information requirements for each ASR/Sampling Plan.

• Prioritize Document Control submissions and lead the document review process for timely approvals.

• Provide guidance to other departments on regulatory and in-house requirements for documenting incoming raw materials and approving new vendors.

Distribute Materials of Origin (MAO) surveys to evaluate raw materials and new vendors.

• Review existing MAO Surveys to determine if updates are needed.

• Collaborate with departments to streamline processes and enhance interdepartmental communication for evaluating and approving new MAO and vendors.

• Organize and maintain a system to track seed and cell records (Master, Working, and production seeds) for easy tracing of final product lineage and MAO.

• Conduct inspections and audits related to MAO issues and seed/cell tracing.

• Stay current with 9 CFR, 21 CFR, and other applicable regulations.

• Provide training for Regulatory staff.

• Manage new product development initiatives.

• Support Quality Assurance efforts.

• Perform other assigned duties as required.

Additional Skills & Qualifications:

• Bachelor's degree in biological sciences required; Master's degree preferred.

• Experience or special interest in new business development, statistical analysis, document control, clinical trials, USDA and FDA regulatory support, technical writing, and research and development is advantageous.

• Intermediate proficiency with Microsoft Office Suite, internet software, email, and electronic document control systems.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.