Pharmaceutical Regulatory Affairs Specialist Job Vacancy in Keetmanshoop, Namibia – Healthcare and Pharmaceuticals

Job Description

Position: Pharmaceutical Regulatory Affairs Specialist

Company: Pfizer Namibia

Location: Keetmanshoop, Namibia

Experience: 5+ years in pharmaceutical regulatory affairs or related field

Education: Bachelor’s degree in Pharmacy, Life Sciences, Regulatory Affairs, or related field; Master’s degree or Regulatory Affairs Certification (RAC) preferred

Employment Type: Full-time

Industry: Healthcare and Pharmaceuticals

Department: Regulatory Affairs

Vacancies:1

Company Overview

Pfizer Namibia is a leading global biopharmaceutical company committed to applying science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of healthcare products, including innovative medicines and vaccines. Our presence in Namibia reflects our dedication to improving health outcomes across Southern Africa by ensuring access to essential medicines and advancing public health initiatives. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. Our portfolio includes medicines and vaccines across a broad range of therapeutic areas, and we are committed to leveraging our scientific expertise to address unmet medical needs in Namibia and beyond. As a company grounded in science and innovation, we are focused on making a meaningful difference in the lives of patients and communities we serve.

Job Overview

We are seeking a highly skilled and detail-oriented Pharmaceutical Regulatory Affairs Specialist to join our team in Keetmanshoop. This critical role involves ensuring that all pharmaceutical products meet the stringent regulatory requirements set by the Namibia Medicines Regulatory Council (NMRC) and other relevant authorities. The successful candidate will be responsible for preparing, submitting, and managing regulatory applications, maintaining compliance with local and international regulations, and serving as the primary liaison between Pfizer and regulatory bodies. This position offers an exciting opportunity to contribute to public health in Namibia by facilitating the availability of safe and effective medicines. The role requires a deep understanding of regulatory frameworks, excellent project management skills, and the ability to navigate complex regulatory landscapes. You will work closely with cross-functional teams including clinical development, quality assurance, and marketing to ensure regulatory strategies align with business objectives. This position is ideal for a professional passionate about regulatory science and committed to making a tangible impact on healthcare in Namibia. For more Jobs in Namibia and career opportunities, visit our partner portal.

Key Responsibilities

• Prepare, compile, and submit regulatory applications, including new drug applications, variations, renewals, and clinical trial applications to the Namibia Medicines Regulatory Council (NMRC).
• Maintain current knowledge of Namibian and regional (e.g., Southern African Development Community) regulatory requirements and guidelines affecting pharmaceutical products.
• Serve as the primary point of contact for all regulatory communications with the NMRC and other health authorities in Namibia.
• Review and approve promotional materials, labeling, and packaging to ensure compliance with regulatory standards and marketing authorization.
• Coordinate and manage regulatory inspections, audits, and queries from health authorities, ensuring timely and accurate responses.
• Develop and implement regulatory strategies for product registration and lifecycle management to optimize approval pathways and timelines.
• Collaborate with global regulatory affairs teams to align local regulatory activities with corporate strategies and ensure consistency in regulatory submissions.
• Maintain regulatory databases and tracking systems to ensure all product licenses and registrations are current and compliant.
• Provide regulatory guidance and training to internal stakeholders on compliance requirements and changes in regulations.
• Participate in cross-functional project teams to provide regulatory input for product development, clinical trials, and post-marketing activities.

Required Skills

• In-depth knowledge of Namibian pharmaceutical regulations and guidelines, with familiarity with SADC and ICH guidelines.
• Strong analytical and problem-solving skills with exceptional attention to detail.
• Excellent written and verbal communication skills for effective interaction with regulatory authorities and internal teams.
• Proven ability to manage multiple projects simultaneously and meet strict regulatory deadlines.
• High proficiency in regulatory documentation preparation and electronic submission systems.
• Strong interpersonal skills with the ability to work collaboratively in a cross-functional environment.
• Ability to interpret complex scientific and clinical data for regulatory purposes.
• Proactive mindset with the ability to anticipate regulatory challenges and propose effective solutions.
• Ethical integrity and commitment to maintaining the highest standards of regulatory compliance.

Education

A Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Chemistry, Biology, or a related field is required. A Master’s degree in Regulatory Affairs, Drug Development, or a related discipline is highly preferred. Professional certification such as Regulatory Affairs Certification (RAC) or equivalent is a significant advantage. Continuous education in regulatory science, pharmacovigilance, or quality management is encouraged and supported by the company.

Experience

Minimum of 5 years of direct experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry. Demonstrated experience in preparing and submitting successful regulatory applications to the Namibia Medicines Regulatory Council or similar authorities in the Southern African region. Experience with product lifecycle management, including post-approval variations and renewals. Previous involvement in regulatory inspections or audits is highly desirable. Experience working in a global or multinational pharmaceutical company is advantageous.

Benefits

• Competitive salary package with performance-based bonuses and comprehensive medical insurance.
• Retirement savings plan with company matching contributions and long-term investment options.
• Generous paid time off, including annual leave, sick leave, and public holidays.
• Continuous professional development opportunities, including attendance at international regulatory conferences and specialized training programs.
• Support for further education and professional certification in regulatory affairs.
• Employee assistance programs and wellness initiatives to support work-life balance.
• Opportunities for career advancement within a global pharmaceutical leader.
• Access to cutting-edge technology and regulatory information systems.

Training

• Comprehensive onboarding program covering Pfizer’s regulatory processes, systems, and corporate standards.
• Specialized training in Namibian and regional regulatory requirements and submission procedures.
• Advanced workshops on regulatory strategy development and lifecycle management.
• Training on electronic document management and regulatory submission systems.
• Professional development courses in leadership, project management, and scientific communication.
• Regular updates on changes in regulatory guidelines and industry best practices.

Working Environment

You will work in a modern, professional office environment in Keetmanshoop with access to state-of-the-art technology and regulatory resources. The role involves a combination of independent work and collaboration with local and international teams. Some flexibility in working hours may be required to accommodate meetings with global colleagues in different time zones. The position may involve occasional travel within Namibia for regulatory meetings or training sessions. Pfizer fosters an inclusive, innovative, and supportive culture where employees are encouraged to develop their expertise and contribute to meaningful healthcare solutions.

Application Process

Interested candidates who meet the qualifications are invited to submit their detailed CV and a cover letter outlining their regulatory experience and motivation for applying. Applications should be submitted through our official online portal. Only shortlisted candidates will be contacted for interviews. The selection process may include multiple interview rounds, a practical assessment, and reference checks. For additional Career Opportunities in Namibia and regional positions, please visit our partner site.

Equal Opportunity Statement

Pfizer Namibia is an equal opportunity employer committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by applicable laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training. We make hiring decisions based solely on qualifications, merit, and business needs at the time.