Pharmaceutical Regulatory Affairs Manager

Placements24; USA; Remote; USD 140.000 - 200.000; Vollzeit

Benefits dieser Stelle

Health insurance

Retirement contributions

Remote-first culture

Zusammenfassung

Placements24 is actively seeking an experienced Regulatory Affairs Manager to steer regulatory strategy across global markets in a fully remote capacity. You will guide product development, submissions, and post-market activities to ensure compliant, timely approvals and safe, effective medicines for patients worldwide.

The role requires senior expertise, strong leadership, and the ability to liaise with health authorities (FDA, EMA, SAHPRA) while supporting cross-functional teams in a

Qualifikationen

• Advanced degree (Master's or PhD) in Pharmacy, Chemistry, Biology, or related field.
• 8+ years in pharmaceutical regulatory affairs with global knowledge.
• Proven track record of successful regulatory submissions and approvals.
• In-depth knowledge of ICH guidelines, CTD format, and regional procedures.
• Experience managing product lifecycle, including post-approval changes.
• Excellent strategic thinking, analytical, and problem-solving skills.
• Exceptional communication, negotiation, and interpersonal skills.
• Ability to work independently and manage multiple projects remotely.
• Fluency in English; knowledge of other languages is a plus.

Aufgaben

• Develop and implement global regulatory strategies for pharmaceutical product registration and lifecycle management.
• Prepare, review, and submit regulatory dossiers (CTD, NDA, ANDA) to health authorities worldwide.
• Liaise with agencies including SAHPRA, FDA, and EMA to address queries and facilitate approvals.
• Monitor evolving regulatory landscapes, guidelines, and legislation.
• Provide regulatory guidance to R&D, manufacturing, and marketing.
• Manage post-approval regulatory activities (variations, renewals, annual reports).
• Oversee regulatory review of promotional materials and labeling.
• Conduct regulatory intelligence to identify opportunities and risks.
• Lead and mentor junior regulatory staff as the team grows.

Kenntnisse

Regulatory strategy

Regulatory submissions

Cross-functional leadership

Communication & negotiation

Ausbildung

Master's or PhD in Pharmacy, Chemistry, Biology or related

Jobbeschreibung

About the Role

Our client, a dynamic pharmaceutical company, is seeking an experienced Regulatory Affairs Manager to lead their regulatory strategies from a fully remote capacity. This is a crucial role where you will be responsible for ensuring compliance with all relevant health authority regulations across various markets. As a remote-first organization, we empower our employees to contribute their expertise from anywhere, fostering a culture of trust and autonomy. You will play a key role in guiding product development, submission processes, and post-market activities, ensuring that our client's innovative medicines reach patients safely and effectively. This is an exceptional opportunity for a seasoned regulatory professional looking to make a significant impact in a flexible, remote environment.

Key Responsibilities

• Develop and implement global regulatory strategies for pharmaceutical product registration and lifecycle management.
• Prepare, review, and submit regulatory dossiers (e.g., CTD, NDA, ANDA) to health authorities worldwide.
• Liaise directly with regulatory agencies, including the SAHPRA, FDA, and EMA, to address queries and facilitate approvals.
• Monitor and interpret evolving regulatory landscapes, guidelines, and legislation.
• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
• Manage post-approval regulatory activities, such as variations, renewals, and annual reports.
• Oversee the regulatory review of promotional materials and product labeling.
• Conduct regulatory intelligence activities to identify potential opportunities and risks.
• Lead and mentor junior regulatory affairs personnel as the team grows.

Requirements

• Advanced degree (Master's or PhD) in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 8 years of experience in pharmaceutical regulatory affairs, with a strong understanding of global regulatory requirements.
• Proven track record of successful regulatory submissions and approvals.
• In-depth knowledge of ICH guidelines, CTD format, and regional regulatory procedures.
• Experience in managing regulatory aspects of product lifecycle, including post-approval changes.
• Excellent strategic thinking, analytical, and problem-solving skills.
• Exceptional communication, negotiation, and interpersonal skills.
• Ability to work independently and manage multiple projects simultaneously in a remote setting.
• Fluency in English is essential; knowledge of other languages is a plus.

Benefits

Our client offers a highly competitive salary, performance-based bonuses, and a comprehensive benefits package, including health insurance and retirement contributions. As a fully remote position, you will benefit from exceptional work-life balance and the freedom to manage your professional life effectively. Continuous learning and professional development opportunities are provided, along with a supportive and collaborative virtual team environment. Join a company at the forefront of pharmaceutical innovation and contribute to bringing essential medicines to patients worldwide.