About Company
Roche Mozambique is a proud affiliate of Roche, a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. For over 125 years, Roche has been contributing to human health by delivering innovative solutions for major medical challenges. In Mozambique, we are dedicated to making a significant impact on public health by ensuring access to essential medicines and diagnostic solutions, particularly in critical areas like oncology, immunology, and infectious diseases. We operate with a strong commitment to ethical practices, scientific integrity, and patient-centricity, striving to build a healthier future for the Mozambican community. Joining Roche means becoming part of a diverse and dynamic team that values collaboration, innovation, and continuous learning, all working towards a common goal of making a difference in the lives of patients.
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Job Description
We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our dedicated team in Maputo, Mozambique. In this pivotal role, you will be instrumental in ensuring that all our pharmaceutical products and diagnostic solutions comply with the local regulatory requirements set by the Mozambican health authorities. This involves navigating a complex landscape of regulations, preparing and submitting comprehensive dossiers, managing product registrations, and maintaining a robust regulatory intelligence function. The ideal candidate will possess a strong understanding of drug development processes, a keen eye for detail, and excellent communication skills to liaise effectively with internal teams and external stakeholders. This is an exciting opportunity for a professional who is passionate about public health and ensuring that life-saving innovations reach patients safely and efficiently across Mozambique.
Key Responsibilities
- Prepare, compile, and submit high-quality regulatory dossiers (e.g., new registrations, variations, renewals) to the Mozambican regulatory authorities (e.g., INFARMED).
- Monitor and interpret new and evolving local and regional regulatory requirements, ensuring timely communication and implementation within the organization.
- Act as the primary point of contact and liaison with local regulatory authorities on all product-related matters, fostering strong and collaborative relationships.
- Provide expert regulatory guidance and support to cross-functional teams, including commercial, medical, and quality assurance, throughout the product lifecycle.
- Manage and maintain product registrations, licenses, and other regulatory documents, ensuring all are current and compliant.
- Participate in the review of promotional materials and product labeling to ensure compliance with approved product information and local regulations.
- Support global regulatory strategies by providing local insights and contributing to regional regulatory projects.
- Conduct regulatory intelligence activities to anticipate future regulatory trends and their potential impact on Roche's portfolio in Mozambique.
- Ensure all activities are conducted in accordance with Roche's internal policies, global standards, and local ethical guidelines.
Required Skills
- Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related field.
- Minimum of 3 years of experience in Regulatory Affairs within the pharmaceutical or healthcare industry, preferably in Mozambique or Sub-Saharan Africa.
- Proven experience in preparing and submitting regulatory dossiers for pharmaceutical products.
- In-depth knowledge of Mozambican pharmaceutical regulations (e.g., INFARMED guidelines) and international standards (e.g., WHO guidelines).
- Excellent written and verbal communication skills in English and Portuguese (mandatory).
- Strong analytical and problem-solving abilities, with meticulous attention to detail.
- Ability to work independently and as part of a cross-functional team in a fast-paced environment.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Preferred Qualifications
- Master's degree or postgraduate qualification in Regulatory Affairs, Pharmaceutical Management, or a related discipline.
- Experience with both pharmaceutical products and medical devices/diagnostics regulatory processes.
- Demonstrated project management skills and ability to manage multiple priorities effectively.
- Familiarity with eCTD (electronic Common Technical Document) submissions.
Perks & Benefits
- Competitive Salary: Rewarding your expertise and contribution with an attractive compensation package.
- Comprehensive Health Coverage: Access to top-tier medical and dental insurance plans for you and your family, ensuring peace of mind.
- Pension Plan: Robust retirement savings plan to help you build a secure financial future.
- Professional Development: Opportunities for continuous learning, training, and career advancement within a global organization.
- Work-Life Balance: Policies and programs designed to support a healthy integration of your professional and personal life.
- Employee Assistance Program: Confidential counseling and support services for personal and work-related challenges.
- Transportation Allowance: Support for your daily commute to ensure ease of access to our Maputo office.
- Annual Leave: Generous paid time off to recharge and pursue personal interests.
How to Apply
Interested candidates are invited to submit their comprehensive resume and a cover letter detailing their relevant experience and qualifications for this role. Please ensure your application highlights your proficiency in both English and Portuguese, and your specific experience with Mozambican regulatory frameworks. Kindly click on the application link below to proceed with your submission.
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