Senior Regulatory Affairs Specialist

About the Role Our client is seeking a highly experienced and strategic Senior Regulatory Affairs Specialist to lead their regulatory efforts.
This is a fully remote position, offering a unique opportunity to shape regulatory strategies from anywhere.
You will be responsible for ensuring compliance with all relevant national and international regulations governing pharmaceutical products.
This role requires a deep understanding of the drug development lifecycle, regulatory submission processes, and a proactive approach to navigating the complex regulatory landscape.
Your expertise will be instrumental in bringing life-saving therapies to market efficiently and ethically.
Key Responsibilities Develop and implement global regulatory strategies for new drug applications (NDAs) and other regulatory submissions.
Prepare, review, and submit regulatory documents to health authorities such as the SAHPRA, FDA, and EMA.
Liaise directly with regulatory agencies to address queries and facilitate the approval process.
Maintain up-to-date knowledge of evolving regulatory requirements and advise the organization accordingly.
Oversee post-market regulatory activities, including variations, renewals, and compliance reporting.
Mentor junior regulatory affairs personnel and contribute to the development of departmental processes and best practices.
Requirements Master's degree or PhD in Pharmacy, Chemistry, Life Sciences, or a related field.
Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
Proven track record of successful regulatory submissions and approvals in major markets.
Extensive knowledge of ICH guidelines, GCP, GMP, and relevant regional regulations.
Excellent strategic thinking, problem-solving, and project management skills.
Exceptional written and verbal communication skills, essential for remote collaboration and agency interactions.
Benefits Highly competitive annual salary and bonus structure.
Fully remote work arrangement with significant autonomy.
Comprehensive executive-level health and wellness benefits.
Generous vacation policy and opportunities for international travel.
Professional development budget for conferences, training, and certifications.
A dynamic and forward-thinking work culture with a focus on innovation.
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