Regulatory Affairs Specialist

Job Description

We are seeking a detail-oriented Regulatory Affairs Specialist to join our compliance management team in Worcester. The ideal candidate will be responsible for ensuring that all pharmaceutical products meet the necessary regulatory requirements, play a crucial role in the approval process, and contribute to maintaining the quality standards of our operations.

Responsibilities

• Develop and maintain regulatory documentation and systems.
• Coordinate and prepare responses to regulatory inquiries.
• Monitor and ensure compliance with GMP, GDP, and other regulatory standards.
• Maintain records of submissions and regulatory interactions.
• Foster relationships with regulatory bodies and stakeholders.
• Identify and mitigate regulatory risks associated with product development.
• Assist in the drafting of technical documentation for submissions.
• Support the commercialization process with regulatory insights.

Requirements

Education

• Bachelor's degree in Regulatory Affairs, Pharmacy, or related field
• Master's degree preferred

Experience

• 5+ years of experience in regulatory affairs within the pharmaceutical or biotech industry

Technical Skills

• Regulatory Strategy Development
• Clinical Trials Regulations

Soft Skills

• Interpersonal Skills
• Organisational Skills

Certifications

• Certified Regulatory Affairs Professional (CRAP)

Languages

• English: Fluent

Advantageous

• Experience with international regulations: Knowledge of international regulatory requirements for pharmaceuticals.
• Understanding of pharmacovigilance: Basic understanding of pharmacovigilance and risk management principles.

Benefits

• Comprehensive health benefits including medical, dental, and vision
• 401(k) with generous employer contributions
• Flexible scheduling and remote work opportunities
• Employee wellness programs
• Professional development and training opportunities

Company Culture

• Inclusiveness: We believe in inclusivity and diversity within our teams, driving creativity and innovation.
• Employee Development: We invest in our employees' development through comprehensive training and career advancement opportunities.
• Work-Life Balance: We value work-life balance, offering flexible work arrangements to support our employees' well-being.