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Regulatory Affairs Specialist
3 months ago
For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world's largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
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 Company 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 the Company, regulatory bodies and customers are appropriately considered and delivered against
•Effectively communicate on a timely basis with management, Company 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 the Company'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
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.
Hours: 8:00am to 5:00pm
Location: Remote
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
