Remote Pharmaceutical Affairs Manager

Placements24; Roanoke (VA); Hybrid; USD 140,000 - 200,000; Full time

Benefits offered by this job

Performance-based bonuses

Health insurance

Retirement planning

Remote work

Job summary

Placements24 seeks a seasoned Pharmaceutical Affairs Manager for a fully remote role, steering global regulatory submissions and ensuring compliance across markets. The successful candidate will drive regulatory strategy, oversee dossier preparation and submissions, and liaise with health authorities to facilitate approvals.

This role emphasizes leadership of distributed teams and strategic input to R&D and manufacturing.

Qualifications

• 7+ years of progressive experience in pharmaceutical regulatory affairs with a track record in global submissions.
• Master's degree or PhD in Pharmacy, Chemistry, Biology, or related scientific discipline.
• Demonstrated ability to lead cross-functional teams remotely and manage complex projects.
• Excellent written and verbal communication for remote collaboration.

Responsibilities

• Develop and execute global regulatory strategies for product development and commercialization.
• Prepare, review, and submit regulatory dossiers to health authorities worldwide.
• Serve as primary contact for regulatory agencies and facilitate approvals.
• Ensure ongoing compliance with national and international regulations.
• Provide strategic input to R&D, manufacturing, and commercial teams.

Skills

Regulatory strategy

Global submissions

Remote team leadership

Regulatory intelligence

Cross-functional collaboration

Education

Master's degree or PhD in a related scientific discipline

Tools

Regulatory intelligence tools

CTD knowledge

Job description

About the Role

Our client, a globally recognized pharmaceutical leader, is seeking a seasoned and highly motivated Pharmaceutical Affairs Manager to join their expanding remote team. This is a fully remote position, offering the flexibility to work from home while playing a crucial role in the strategic management of pharmaceutical affairs. The Manager will be responsible for overseeing regulatory submissions, ensuring compliance, and contributing to the global product strategy. The ideal candidate will possess extensive experience in pharmaceutical regulatory affairs and a proven ability to manage complex projects from a distance. This role demands strong leadership, excellent communication skills, and a deep understanding of the pharmaceutical landscape. We are looking for a self-driven individual who can effectively collaborate with cross-functional teams and drive regulatory success in a virtual environment. Embrace a career that offers both significant professional challenge and the convenience of remote work with a company that values innovation and global reach.

Key Responsibilities

• Develop and execute global regulatory strategies for pharmaceutical product development and commercialization.
• Manage the preparation, review, and submission of regulatory dossiers to health authorities worldwide.
• Serve as a key point of contact for regulatory agencies, addressing inquiries and facilitating approvals.
• Ensure ongoing compliance with all applicable national and international pharmaceutical regulations.
• Provide expert regulatory guidance and strategic input to R&D, manufacturing, and commercial teams.
• Monitor regulatory intelligence, assess impact on company strategies, and advise on necessary adjustments.
• Oversee post-approval regulatory activities, including variations, renewals, and annual reporting.
• Collaborate with international regulatory counterparts to ensure alignment and harmonization of strategies.
• Contribute to the development and implementation of company-wide regulatory policies and procedures.
• Lead and mentor junior regulatory affairs professionals within the remote team structure.

Requirements

• Master's degree or Ph.D. in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs, with a strong track record in global submissions.
• Demonstrated expertise in navigating diverse international regulatory environments and health authority requirements.
• Proven experience in managing complex regulatory projects and leading cross-functional teams remotely.
• In-depth knowledge of regulatory submission formats (e.g., CTD) and regulatory intelligence tools.
• Exceptional strategic thinking, analytical, and problem-solving capabilities.
• Outstanding written and verbal communication and presentation skills, suitable for remote interaction.
• Proficiency in using virtual collaboration tools and managing remote workflows.
• Ability to work autonomously, demonstrate strong initiative, and manage multiple priorities effectively.
• Previous experience in a remote or distributed work environment is highly desirable.
• A passion for staying at the forefront of pharmaceutical regulatory science.

Benefits

• Our client offers a highly competitive salary, performance-based bonuses, and an excellent benefits package including comprehensive health insurance and retirement planning.
• This is a fully remote position, offering unparalleled flexibility and the opportunity to achieve a superior work-life balance.
• Employees benefit from continuous professional development, access to global industry insights, and opportunities for significant career advancement within a leading pharmaceutical organization.
• Our client provides a supportive virtual work environment, fosters innovation, and invests in its employees' growth.
• Additional perks include potential for travel to key international conferences and exposure to cutting-edge pharmaceutical development.