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REMOTE Regulatory Affairs Specialist

2 months ago

Trenton, United States Raland Compliance Partners, LLC Full time

The Regulatory Affairs function is responsible for ensuring that the company aligns with all of the regulations and laws pertaining to our business; Working with federal, state, and local regulatory agencies on specific issues affecting our business; and advises the company on the regulatory aspects and climate that would affect proposed activities.

The Regulatory Affairs Specialist will assist in providing regulatory services to management for the Global Regulatory Affairs (GRA) group throughout the functional operations of improving entire drug development and commercialization process in areas including document authorship and review, preparation of applications for global submission, authorship and review to deficiency responses, and maintaining current regulatory practices and expectations. In addition, the Regulatory Affairs Specialist will assist in preparing for legislative and regulatory group meetings and communications as appropriate.

* Plan, coordinate, and drive the development and evaluation of assigned components of new drug substance and drug product regulatory strategies and submissions from development through commercialization
* Manage resources and ensure appropriate review and oversight for multiple submission components within the Client portfolio
* Analyze and provide regulatory leadership and mentoring to individuals, functional area and overall organization
* Work closely with management, customers and strategic partners to ensure the needs of Client, regulatory bodies and customers are appropriately considered and delivered against
* Effectively communicate on a timely basis with management, Client functional areas and customers regarding matters to set specifications, author scientific research reports and their regulatory importance
* Conduct regular quality audits and develop quality management systems in compliance with pharmaceutical standards for GMP (Good Manufacturing Practices) / GLP (Good Laboratory Practices)
* Represent functional area and projects at local, technical, governance, executive and customer meetings
* Communicate and ensure staff awareness and understanding of Client's strategy, initiatives, expectations, processes, and portfolio status
* Evaluate changes to procedures and products for impact to regulatory filings.
* Evaluate document request and provide appropriate documents in support of client and regulatory agency audits.
* Actively participate in client and regulatory agency audits.

* Conduct assessments and identify areas of improvement to regulatory aspects of drug development and commercial operations; propose and implement process improvements
* Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met
* Perform other duties as required

Job Requirements

Education or Equivalent Requirements:

* Bachelor's degree in a life science or related field preferred
* Minimum 5 years of experience in Regulatory Affairs, Quality Assurance or related field or any combination
* Experience working in a manufacturing, pharmaceutical and/or GMP facility
* Must be detail oriented with well-developed analytical skills.
* Ability to interpret subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations.
* Ability to work in a self-directed manner to see issues through to completion.

Knowledge/Skills Requirements:

* Ability to multi-task and demonstrate diplomatic skills
* Proficient (excellent) in English verbal and written communication skills to convey and receive ideas and instructions to/from others within and outside the organization.

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