Senior CMC Regulatory Affairs Drug & Device (Combination Products) Consultant, FSP (Remote US o[...]

Parexel; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Senior CMC Regulatory Affairs Consultant to provide strategic regulatory guidance for combination products and medical devices. This remote role involves leading global CMC regulatory strategies, ensuring compliance, and collaborating with international teams. The ideal candidate will have extensive experience in regulatory affairs, particularly in pharma or biotech, and a strong understanding of FDA and ICH regulations. This position offers the opportunity to influence drug development strategies and contribute to high-quality regulatory submissions in a dynamic and collaborative environment.

Qualifications

• 6+ years of CMC regulatory experience in pharma or biotech.
• Regulatory Affairs Certification highly preferred.

Responsibilities

• Lead CMC regulatory strategies for combination products/medical devices.
• Prepare documentation for global regulatory filings.

Skills

FDA Regulations

ICH Regulations

Document Review

Communication Skills

Collaboration

Education

Bachelor's Degree in Scientific Discipline

Master's Degree

PhD or PharmD

Job description

Senior CMC Regulatory Affairs Drug & Device (Combination Products) Consultant, FSP (Remote US or Canada)

Join to apply for the Senior CMC Regulatory Affairs Drug & Device (Combination Products) Consultant, FSP (Remote US or Canada) role at Parexel.

This role involves providing strategic regulatory guidance to cross-functional project teams, recommending and implementing global CMC regulatory strategies, and ensuring compliance with regulatory requirements for combination products and medical devices. The consultant will work with international teams, prepare documentation for global filings, and support post-marketing activities, ensuring a seamless development and registration process.

Key Responsibilities

1. Lead development and implementation of CMC regulatory strategies for combination products/medical devices, ensuring alignment with project timelines.
2. Coordinate with global teams across Japan, Europe, US/Canada, and project management to support development and commercial activities.
3. Manage RA CMC regulatory activities for global projects, providing strategic recommendations.
4. Ensure compliance for post-approval changes and submissions in the US/Canada.
5. Prepare and liaise on CMC documentation for global regulatory filings, including technical content for submissions.
6. Communicate regulatory expectations effectively to technical and non-technical teams.
7. Advise on regulatory requirements for drug-device combinations and medical devices.
8. Contribute to high-quality regulatory submissions and responses, including reviews and strategy development.
9. Support globalization efforts by advising teams in Japan, Europe, and US/Canada on US regulatory frameworks.
10. Monitor legislative and regulatory changes, contributing to risk assessments and policy updates.
11. Represent the regulatory function in product evaluations and collaborate with external contractors and cross-functional teams.
12. Provide regulatory support during inspections and audits, and guide internal stakeholders on risk management.
13. Maintain current regulatory knowledge and develop policies and SOPs for compliance.

Qualifications

• Bachelor’s or Master’s degree in a scientific discipline; PhD or PharmD preferred.
• Regulatory Affairs Certification highly preferred.
• At least 6 years of CMC regulatory experience in pharma or biotech.
• Knowledge of regulatory frameworks for combination products/medical devices in major markets.
• Experience with registration of combination products/medical devices.
• Proven track record in drug development strategies and global regulatory submissions.
• Experience with US and international drug development processes, including post-marketing.

Skills

• Strong understanding of FDA, ICH regulations for investigational and approved products.
• Attention to detail and accuracy in document review.
• Excellent written and verbal communication skills.
• Ability to collaborate across functions and build professional relationships.
• Willingness to travel up to 10%, with potential international travel.

Candidates located on the east coast are preferred, but flexible candidates working east coast hours will also be considered.