Regulatory Affairs Specialist

Vintti is a specialized staffing agency that believes diversity is the catalyst for innovation. We connect US-based SMBs, startups, and firms with exceptional talent from Latin America, fostering a rich tapestry of cultural perspectives within American businesses. Our unique position allows us to handpick professionals who not only possess the required skills but also bring fresh ideas and global insights to the table. Vintti's services go beyond filling positions; we enrich company cultures and expand business horizons on an international scale.

A Regulatory Affairs Specialist plays a crucial role in ensuring that a company's products meet all regulatory standards and compliance requirements. This role involves staying up to date with the latest regulations, preparing and submitting necessary documentation to regulatory bodies, and liaising with internal departments to ensure all processes align with current laws and guidelines. Additionally, Regulatory Affairs Specialists monitor post-market activities to maintain compliance and work on risk management strategies, ensuring that the company can effectively and efficiently bring their products to market while adhering to legal requirements.

- Bachelor's degree in life sciences, pharmacy, engineering, or a related field
- Minimum of 3 years of experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry
- Comprehensive understanding of regulatory requirements and guidelines (e.g., FDA, EMA, ICH)
- Proven experience preparing and submitting regulatory documents such as INDs, NDAs, and BLAs
- Strong knowledge of regulatory processes and submission requirements for domestic and international markets
- Effective communication and interpersonal skills
- Ability to interpret regulatory information and communicate effectively to cross-functional teams
- Experience with electronic submission software and regulatory databases
- Strong analytical and problem-solving skills
- Attention to detail and meticulous organizational skills
- Ability to manage multiple projects and deadlines efficiently
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)
- Experience in project management and coordination
- Ability to work independently and as part of a team
- Adaptability to a fast-paced and rapidly changing environment
- Experience in regulatory inspections and audits
- Ability to critically evaluate scientific and technical information
- Knowledge of quality assurance and compliance principles
- Experience in drafting and maintaining standard operating procedures (SOPs)
- Understanding of regulatory affairs’ role in product development and lifecycle management

- Review and interpret regulatory requirements and guidance documents to ensure compliance
- Prepare and submit regulatory documents such as INDs, NDAs, BLAs, or other submissions to regulatory bodies
- Maintain regulatory files/database and chronologies in good order
- Assess regulatory intelligence and maintain current knowledge of applicable regulatory requirements
- Compile and review quality metrics, reports, and documentation to ensure adherence to regulatory protocols
- Act as a liaison between the company and regulatory authorities
- Coordinate, prepare, or review regulatory submissions for domestic and international projects
- Monitor and track regulatory submissions and approval status
- Provide regulatory guidance to project teams during product development and commercialization
- Participate in the development and implementation of regulatory strategies and plans
- Conduct regulatory reviews of labeling and promotional materials
- Assist in the training of staff on regulatory processes and requirements
- Support product recalls and field corrective actions, ensuring regulatory compliance
- Coordinate with cross-functional teams, including Clinical, Quality Assurance, and Marketing
- Review, interpret, and summarize regulations, guidelines, and industry standards
- Draft, review, and maintain standard operating procedures (SOPs) and policies
- Manage relationships and communications with external regulatory consultants and contractors
- Participate in regulatory inspections and audits and prepare audit responses
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly
- Identify and assess regulatory risks and provide mitigation strategies

The ideal candidate for the Regulatory Affairs Specialist role will possess a Bachelor's degree in life sciences, pharmacy, engineering, or a related field, coupled with a minimum of 3 years of hands-on experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry. Demonstrating a comprehensive understanding of regulatory requirements and guidelines from entities such as FDA, EMA, and ICH, the candidate will have a proven track record in preparing and submitting key regulatory documents, including INDs, NDAs, and BLAs. Exceptional analytical and problem-solving skills, combined with meticulous attention to detail and superior organizational capabilities, will enable the candidate to effectively manage multiple projects and meet strict deadlines. Proficient in using electronic submission software, regulatory databases, and the Microsoft Office Suite, they will also have a robust background in quality assurance and compliance principles. Effective written and verbal communication skills, paired with strong interpersonal abilities, will allow the candidate to seamlessly interpret regulatory information and provide precise guidance to cross-functional teams. As a proactive and self-motivated professional, they will demonstrate adaptability to fast-paced, ever-changing environments and exhibit a strong sense of initiative, reliability, and accountability. The ideal candidate will show a keen enthusiasm for staying updated with current regulatory trends, and their collaborative nature will make them a valuable team player committed to high standards of regulatory compliance and continuous professional development.

- Review and interpret regulatory requirements and guidance documents to ensure compliance
- Prepare and submit regulatory documents such as INDs, NDAs, BLAs, or other submissions to regulatory bodies
- Maintain regulatory files/database and chronologies in good order
- Assess regulatory intelligence and maintain current knowledge of applicable regulatory requirements
- Compile and review quality metrics, reports, and documentation to ensure adherence to regulatory protocols
- Act as a liaison between the company and regulatory authorities
- Coordinate, prepare, or review regulatory submissions for domestic and international projects
- Monitor and track regulatory submissions and approval status
- Provide regulatory guidance to project teams during product development and commercialization
- Participate in the development and implementation of regulatory strategies and plans
- Conduct regulatory reviews of labeling and promotional materials
- Assist in the training of staff on regulatory processes and requirements
- Support product recalls and field corrective actions, ensuring regulatory compliance
- Coordinate with cross-functional teams, including Clinical, Quality Assurance, and Marketing
- Review, interpret, and summarize regulations, guidelines, and industry standards
- Draft, review, and maintain standard operating procedures (SOPs) and policies
- Manage relationships and communications with external regulatory consultants and contractors
- Participate in regulatory inspections and audits and prepare audit responses
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly
- Identify and assess regulatory risks and provide mitigation strategies

- Detail-oriented with strong organizational skills
- Exceptional analytical and problem-solving abilities
- Excellent written and verbal communication skills
- Effective interpersonal skills and ability to work well within cross-functional teams
- Proactive and self-motivated with a strong sense of initiative
- Ability to manage multiple projects and meet strict deadlines
- Adaptable to fast-paced and continuously changing environments
- High level of integrity and ethical standards
- Strong critical thinking and scientific evaluation capabilities
- Proficient in using electronic submission software and regulatory databases
- Strong project management and coordination skills
- Collaborative team player with a willingness to assist others
- Eager to stay updated with current regulatory trends and requirements
- Reliable and accountable with a strong commitment to accuracy
- Ability to interpret complex regulatory information and provide clear guidance
- Strong understanding of quality assurance and compliance principles
- Demonstrates leadership and decision-making capabilities
- Enthusiastic about learning and professional development
- Committed to maintaining high standards of regulatory compliance

- Competitive salary range
- Comprehensive health insurance (medical, dental, vision)
- Retirement savings plan with company match
- Paid time off (vacation, sick days, holidays)
- Flexible working hours
- Remote work opportunities
- Professional development and training programs
- Tuition reimbursement
- Employee wellness programs
- Life and disability insurance
- Employee assistance program (EAP)
- Performance bonuses and incentives
- Career advancement opportunities
- Paid parental leave
- On-site fitness center or gym membership discounts
- Commuter benefits
- Company-sponsored social events and activities
- Employee discounts on products and services
- Health and wellness stipends