Regulatory Affairs Manager (Pharmaceuticals)

Placements24; Redmond (WA); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive benefits

Remote work arrangements

Job summary

Placements24 is seeking a Regulatory Affairs Manager to lead global regulatory efforts from a remote-based position. This role requires developing regulatory strategies, preparing dossiers, and engaging with health authorities to drive timely approvals and market access.

The ideal candidate will have 8+ years in pharmaceutical regulatory affairs, deep knowledge of ICH and GxP guidelines, and strong communication and negotiation skills to influence product development and compliance worldwide.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or related field.
• 8+ years of progressive pharmaceutical regulatory affairs experience.
• Experience preparing and submitting regulatory applications in US, EU, and other major markets.
• In-depth knowledge of pharmaceutical regulations, ICH guidelines, and GxP.
• Excellent written and verbal communication skills with ability to negotiate with health authorities.

Responsibilities

• Develop and implement global regulatory strategies for product registration and lifecycle management.
• Prepare and submit regulatory dossiers (CTD, NDA, ANDA) to health authorities worldwide.
• Interpret and advise on regulatory requirements and their impact on development and commercialization.
• Liaise effectively with regulatory agencies, providing timely responses to inquiries and facilitating approvals.
• Ensure compliance with applicable regulations, guidelines, and company policies.
• Monitor changes in the regulatory landscape and update strategies accordingly.

Skills

Regulatory strategy

Dossier preparation

Regulatory submissions

Health authority liaison

Communication & negotiation

Education

Bachelor's degree in Pharmacy

Advanced degree preferred

Job description

About the Role

Our client is actively seeking a strategic and knowledgeable Regulatory Affairs Manager to lead their regulatory efforts from a remote-based position. This role is critical for ensuring that all pharmaceutical products comply with national and international regulatory requirements, facilitating timely approvals and market access. You will be responsible for developing and implementing regulatory strategies, preparing submission dossiers, and engaging with health authorities. This is an exceptional opportunity for a seasoned regulatory professional to drive compliance and influence global product strategy for a forward-thinking pharmaceutical company.

Key Responsibilities

• Develop and execute global regulatory strategies for product registration and lifecycle management.
• Prepare and submit high-quality regulatory dossiers (e.g., CTD, ANDA, NDA) to health authorities worldwide.
• Interpret and advise on complex regulatory requirements and their impact on product development and commercialization.
• Liaise effectively with regulatory agencies, providing timely responses to inquiries and facilitating approvals.
• Ensure compliance with all applicable regulations, guidelines, and company policies.
• Monitor changes in the regulatory landscape and update strategies accordingly.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related field; advanced degree preferred.
• Minimum of 8 years of progressive experience in pharmaceutical regulatory affairs .
• Proven experience in preparing and submitting regulatory applications in major markets (e.g., US, EU, South Africa).
• In-depth knowledge of pharmaceutical regulations, ICH guidelines , and GxP.
• Strong strategic thinking, analytical, and problem-solving abilities.
• Excellent written and verbal communication skills, with the ability to negotiate effectively with health authorities.

Benefits

• Highly competitive salary commensurate with experience.
• Comprehensive health and wellness benefits package.
• Flexible remote work arrangement, enabling a superior work-life balance.
• Significant opportunities for career growth and leadership development.
• Be part of a company committed to innovation and improving global health outcomes.