Job Title: Pharmaceutical Regulatory Consultant

 

Job Description:

Our Client is seeking a highly experienced Pharmaceutical Regulatory Consultant to provide expert regulatory guidance, strategy, and process management. This remote position offers a flexible work schedule, working on multiple projects within the pharmaceutical and biotech industries. Ideal for professionals with extensive regulatory experience, this role involves leading regulatory submissions, managing compliance, and ensuring alignment with global regulatory st

 

About the company:

Our Client empowers healthcare companies to deliver innovative solutions through regulatory excellence. By leveraging expertise in global regulatory processes, they assist clients in navigating complex compliance challenges and achieving their regulatory goals efficiently.

 

Work Schedule:

• Flexible work schedule; workload varies based on project demand.
• Typically managing two projects at once, averaging 40 hours per week.

Responsibilities of the role:

• Develop and implement regulatory strategies for FDA, EMA, ICH, and other global regulatory standards.
• Lead regulatory submissions (e.g., BLA, NDA, IND, eCTD), ensuring timely and accurate documentation.
• Provide expert advice on regulatory requirements, risks, and best practices.
• Manage SOPs, quality systems, and regulatory processes.
• Represent clients in regulatory meetings, audits, and inspections.
• Ensure documentation quality through thorough reviews and adherence to regulatory standards.

Required Experience and Qualifications:

• Minimum 3 years of experience in regulatory affairs within the pharmaceutical or biotech industry.
• Bachelor’s degree or higher in life sciences, pharmacy, or related field.
• Regulatory Affairs Certificate (RAC) required.
• Strong knowledge of global regulatory guidelines and processes.
• Proven experience in regulatory strategy and risk management.
• Proficiency in Microsoft Office Suite, Adobe Acrobat, and project management tools.
• High-level familiarity with medical terminology and regulatory frameworks is essential.

Language Requirements:

• C2 Level English proficiency with strong oral and written communication skills.

Preferred Skills:

• Leadership experience in regulatory submissions and process optimization.
• Ability to manage cross-functional teams and multiple projects.
• Familiarity with quality management systems and regulatory compliance tools.

Salary and Benefits:

• Salary paid in USD or Local Currency according to contractor preference.
• Compensation range: Starting at 90 USD/hour, with the potential for higher compensation for exceptional candidates (~14,400 USD per month).
• 1099 contractor position: No benefits are provided.
• Contractors manage their own schedules; all time off is unpaid.