Pharmaceutical Regulatory Affairs Manager

Placements24; Willows (CA); Remote; USD 140,000 - 190,000; Full time

Benefits offered by this job

Remote-first environment

Health insurance

Retirement contributions

Performance bonuses

Flexible schedule

Career development

Job summary

Placements24 is seeking an experienced Regulatory Affairs Manager to lead regulatory strategies for a pharmaceutical portfolio from a fully remote capacity. You will oversee global submissions, liaise with health authorities, and guide product development, ensuring compliance across markets.

The role emphasizes independence, strong communication, and mentorship as the team grows. A Master’s or PhD in a related field and at least 8 years of regulatory experience are required, with fluency in

Qualifications

• Advanced degree in a scientific discipline (Master's or PhD).
• Minimum 8 years of pharmaceutical regulatory affairs experience.
• Proven track record of successful regulatory submissions and approvals.
• Deep knowledge of ICH guidelines, CTD format, and regional regulatory procedures.

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 (SAHPRA, FDA, EMA) to address queries and facilitate approvals.
• Monitor evolving regulatory landscapes, guidelines, and legislation.
• Provide regulatory guidance to cross-functional teams (R&D, manufacturing, marketing).
• Manage post-approval regulatory activities (variations, renewals, annual reports).
• Oversee regulatory review of promotional materials and product labeling.
• Conduct regulatory intelligence to identify opportunities and risks.
• Lead and mentor junior regulatory affairs personnel.

Skills

Strategic thinking

Analytical skills

Problem solving

Communication

Negotiation

Independent work

Education

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

Job description

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.