Remote Senior Regulatory Affairs Specialist - Pharmaceuticals

Placements24; Graafwater; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Health insurance

Home office stipend

Flexible hours

Career growth

Leadership development

Job summary

Placements24 is seeking a highly experienced Senior Regulatory Affairs Specialist for a fully remote role. You will guide regulatory strategy and ensure lifecycle compliance for pharmaceutical products, preparing dossiers for authorities worldwide, including FDA, EMA, and SAHPRA.

You will lead cross-functional teams, monitor evolving guidelines, and oversee post-approval activities while working from a remote setting with global teams.

Qualifications

• Bachelor's or Master's degree in a scientific discipline with regulatory focus.
• Minimum 7 years of progressive experience in pharmaceutical regulatory affairs.
• Proven experience preparing and submitting dossiers to major health authorities.
• Deep knowledge of ICH guidelines and CTD formats.
• Ability to lead regulatory strategy in a global, remote setting.

Responsibilities

• Develop global regulatory strategies for NDAs, MAAs, and variations.
• Prepare and review regulatory submission documents (CTD modules, eCTD).
• Liaise with agencies, respond to queries, manage submissions.
• Provide regulatory guidance to R&D, clinical, manufacturing, and marketing.
• Monitor guidelines and advise on impacts and actions.
• Oversee post-approval activities: reports, supplements, labeling updates.
• Conduct regulatory intelligence to identify trends.
• Maintain regulatory filings and databases.
• Support regulatory inspections and audits.
• Assess regulatory impact of changes in products and processes.

Skills

Regulatory strategy

Dossier submissions

ICH guidelines

Cross-functional collaboration

Remote work

Education

Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or related discipline

Master's degree preferred

Tools

RIMS

Submission gateways

Job description

About the Role

Our client, a globally recognized pharmaceutical company, is seeking a highly experienced and meticulous Senior Regulatory Affairs Specialist for a fully remote position. This critical role involves guiding the regulatory strategy and ensuring compliance for pharmaceutical products throughout their lifecycle, from development to post-market surveillance. You will be responsible for preparing and submitting regulatory dossiers to health authorities worldwide, including the FDA, EMA, and SAHPRA. This is an exceptional opportunity to work remotely, contributing to global health by ensuring timely access to safe and effective medicines. The ideal candidate will possess extensive knowledge of international regulatory requirements, strong analytical skills, and the ability to navigate complex regulatory landscapes. You will be a key advisor on regulatory matters, shaping the success of our client's product portfolio.

Key Responsibilities

• Develop and implement global regulatory strategies for new drug applications (NDAs), marketing authorization applications (MAAs), and variations.
• Prepare, review, and compile high-quality regulatory submission documents (e.g., CTD modules, electronic submissions) for various health authorities.
• Liaise directly with regulatory agencies, responding to queries and managing the submission process.
• Provide regulatory guidance and support to cross-functional teams, including R&D, clinical operations, manufacturing, and marketing.
• Monitor and interpret evolving regulatory guidelines, advising the company on potential impacts and necessary actions.
• Oversee post-approval regulatory activities, including annual reports, supplements, and labeling updates.
• Conduct regulatory intelligence activities to identify trends and anticipate future regulatory requirements.
• Manage and maintain regulatory filings and databases.
• Support regulatory inspections and audits.
• Assess the regulatory impact of product changes and manufacturing processes.

Requirements

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related discipline.
• Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting various types of regulatory dossiers (e.g., INDs, NDAs, MAAs) to major global health authorities.
• In-depth knowledge of relevant regulations, guidelines (e.g., ICH), and submission formats (e.g., CTD).
• Excellent understanding of drug development processes and pharmaceutical manufacturing.
• Strong analytical, problem-solving, and critical thinking skills.
• Exceptional written and verbal communication skills, with the ability to articulate complex regulatory issues clearly and concisely.
• Demonstrated ability to manage multiple projects, prioritize tasks, and meet tight deadlines in a remote work environment.
• Proactive and detail-oriented approach to regulatory compliance.
• Experience with electronic submission gateways and regulatory information management systems is a plus.

Benefits

• Competitive salary, commensurate with experience and the demands of a senior remote role.
• Comprehensive health, dental, and vision insurance coverage.
• Generous home office setup allowance and ongoing support.
• Opportunities for significant professional growth and leadership development.
• Work on a diverse portfolio of innovative pharmaceutical products.
• Flexible working hours to ensure work-life balance.
• Be an integral part of a leading pharmaceutical company's global regulatory success.