Despite significant focus and effort millions of patients in Emerging Markets still lack access to life-saving medicines. These regions are also often deprived of innovative therapies developed in the United States and the European Union, particularly impacting children who could greatly benefit from timely interventions. Barriers such as funding constraints, regulatory hurdles, and supply chain challenges frequently prevent these critical medications from reaching those in need.
At FarmaMondo, we are committed to addressing these challenges. Our teams work tirelessly to provide commercial access to life-saving medicines in emerging markets, making a global impact on health. Each position at FarmaMondo contributes to the success of our business and the world. As a global leader, we seek talented individuals who share our values and mission to create a healthier world.
FarmaMondo is a fast-growing, Swiss-based pharmaceutical group focused on providing market access services and full commercialization for specialty medicines through a unique geographical footprint. Our mission is to provide healthcare professionals and patients with access to both licensed and unlicensed medicines in emerging markets.
To reinforce our Regulatory Affair function, FarmaMondo is currently seeking a Head of Regulatory Affairs for Specialty Medicines for its Headquarters in Chiasso, Switzerland.
The position reports to the Director of Group Quality Assurance, Regulatory Affairs & Pharmacovigilance.
The Head of Regulatory Affairs will lead the regulatory function of FarmaMondo Group ensuring that all products distributed comply with national and international regulations. This role will focus on guiding the company through the regulatory landscape, maintaining relationships with regulatory authorities, and providing strategic oversight of regulatory submissions, approvals, and ongoing compliance processes. The Head of Regulatory Affairs as a business partner will play an important role supporting the business in the interaction with innovators, from the initial phase, through the signing of the agreement, the commercialization and delivery of the pharmaceutical products.
KEY ACCOUNTABILITIES
Leadership and Strategy:
* Develop and implement the regulatory affairs strategy aligned with the company’s goals and compliance requirements.
* Lead the Regulatory Affairs globally, with the support of local consultants, providing guidance and mentoring to ensure regulatory compliance across all departments.
* Collaborate with senior management to ensure regulatory considerations are integrated into business strategies, especially in the business development actively participating in the business cases of new product distribution, market entry, and global expansion.
Regulatory Compliance:
* Oversee all regulatory affairs for the pharmaceutical distribution operations, ensuring compliance with local, regional, and international regulations, both for licensed and unlicensed products.
* Monitor changes in regulations and guidelines, assessing their impact on business operations and advising senior management on necessary adjustments.
* Ensure the timely and accurate submission of regulatory filings and renewals for the company’s pharmaceutical products and services.
Regulatory Submissions and Approvals:
* Lead the regulatory license application and other regulatory import permits applications.
* Lead the preparation and submission of regulatory documentation for new products, product variations, and market access approvals.
* Act as the primary point of contact with regulatory agencies, ensuring efficient communication and the resolution of any compliance issues.
* Coordinate and track the status of all product registration applications and approvals, ensuring deadlines are met.
Regulatory Intelligence and Risk Management:
* Provide regulatory intelligence and stay informed about regulatory trends and upcoming changes through relationships with industry associations, consultants, and experts.
* Conduct regulatory risk assessments and implement proactive measures to mitigate potential challenges.
Cross-Functional Collaboration
* Partner with Business Development, Quality Assurance and Extended Supply Chain to ensure regulatory requirements are met in the distribution of pharmaceutical products.
* Support cross-functional team during audits and inspections, ensuring the company is well-prepared for regulatory reviews.
Documentation and Reporting:
* Ensure that all regulatory documentation is up to date, organized, and compliant with relevant regulatory requirements.
* Provide regular reports to senior management on regulatory performance, compliance status, and any issues related to regulatory affairs.
Crisis Management:
* Address regulatory crises or non-compliance issues swiftly and effectively to safeguard the company’s reputation and operations.
QUALIFICATION AND EXPERIENCE
* Minimum 8 years’ experience in Regulatory Affairs within the pharmaceutical or healthcare industry, with significant exposure to pharmaceutical distribution
* Experience in Named Patient regulatory work in the Emerging Markets and ready to design and present plans to internal and external stakeholders.
* Strong knowledge of local and international regulations governing pharmaceutical products, including distribution, import/export, and market access.
* Proven experience in managing regulatory submissions, approvals, and compliance processes.
* Experience in working with regulatory agencies at both national and international levels.
* Fluency in English is a must
* Proficiency in Microsoft Office is a must and ERP SAP knowledge an advantage
SOFT SKILLS
* Exceptional communication and negotiation skills to interact effectively with internal and external stakeholders.
* Ability to analyze complex regulatory information and provide actionable recommendations.
* Detail-oriented, highly organized, and the ability to manage multiple projects simultaneously.
* Ability to work in a fast-paced environment and adapt to changes in regulations and business needs.
ADDITIONAL INFORMATION
* Full time contract
* Job place in Chiasso (Switzerland)
* Compensation package built up on fixed and variable components
* Ideal starting date is 1st April 2025
Equal Opportunity Statement - FarmaMondo is an equal opportunity employer. We are committed to creating a diverse and inclusive environment for all employees and applicants. We do not discriminate on the basis of race, color, national origin, age, gender, gender identity, sexual orientation, disability, religion, or any other characteristic protected by law. We believe that a diverse workforce enriches our organization and fosters innovation. We are dedicated to providing a work environment that is free from discrimination, harassment, and retaliation, and where all employees are treated with respect and dignity. All employment decisions, including hiring, promotion, compensation, and benefits, are made based on the individual’s qualifications, skills, and experience.
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