Regulatory Affairs Specialist

Placements24; Willows (CA); Hybrid; USD 90,000 - 140,000; Full time

Benefits offered by this job

Competitive salary with incentives

Health, dental, and vision benefits

Paid time off

Job summary

Placements24 is seeking a meticulous Regulatory Affairs Specialist to support our client from a fully remote position. The role focuses on ensuring pharmaceutical products meet global regulatory requirements and involves preparing and submitting documentation, liaising with health authorities, and staying current with evolving regulations.

You will work with R&D, QA, and Marketing to provide regulatory guidance, maintain documentation and databases, and manage multiple projects independently in

Qualifications

• Bachelor's degree in a scientific discipline is required.
• Proven experience in Pharmaceutical Regulatory Affairs.
• Demonstrated experience in preparing and submitting regulatory dossiers.
• Strong understanding of global regulatory requirements (FDA/EMA).
• Excellent written and verbal communication skills.
• Ability to work independently and manage multiple projects remotely.

Responsibilities

• Prepare, review, and submit regulatory submissions to health authorities globally (INDs, NDAs, MAAs).
• Ensure compliance with regulatory requirements, guidelines, and company policies.
• Liaise with regulatory agencies during submissions and reviews.
• Monitor new regulations and assess impact on products and operations.
• Maintain regulatory documentation and databases for accuracy and completeness.
• Collaborate with R&D, QA, and Marketing to provide regulatory guidance.

Skills

Regulatory submissions

FDA/EMA knowledge

Attention to detail

Remote work

Cross-functional collaboration

Education

Bachelor's degree in Pharmacy/Chemistry/Biology

Tools

Regulatory databases

Job description

About the Role

Our client is seeking a meticulous and proactive Regulatory Affairs Specialist to support their operations from Welkom . This role is essential for ensuring that all pharmaceutical products meet stringent regulatory requirements for approval and marketing in various global markets. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and staying abreast of evolving regulations. This is a fully remote position, offering you the flexibility to manage your work effectively while contributing to critical compliance activities. We are looking for an individual with a keen eye for detail and a solid understanding of pharmaceutical regulatory landscapes.

Key Responsibilities

• Prepare, review, and submit regulatory submissions (e.g., INDs, NDAs, MAAs) to health authorities globally.


• Ensure compliance with all applicable regulatory requirements, guidelines, and company policies.


• Liaise effectively with regulatory agencies during the submission and review process.


• Monitor and interpret new and evolving regulations and guidance documents, assessing their impact on the company's products and operations.


• Maintain regulatory documentation and databases, ensuring accuracy and completeness.


• Collaborate with cross-functional teams, including R&D, Quality Assurance, and Marketing, to provide regulatory guidance and support.

Requirements

• Bachelor's degree in a scientific discipline (e.g., Pharmacy, Chemistry, Biology) or a related field.


• Proven experience in Pharmaceutical Regulatory Affairs.


• Demonstrated experience in preparing and submitting various types of regulatory dossiers.


• Thorough understanding of global regulatory requirements and guidelines (e.g., FDA, EMA).


• Excellent written and verbal communication skills, with strong attention to detail.


• Ability to work independently and manage multiple projects effectively in a remote setting.

Benefits

• Competitive annual salary with performance incentives.


• Comprehensive health, dental, and vision benefits package.


• Generous paid time off and holidays.


• Professional development programs and opportunities to attend industry conferences.


• A supportive and collaborative remote work environment.