Leiden Manager, Global Regulatory Affairs Strategy

Job description

Purpose of the Role The Manager, GRA Strategy is responsible for contributing to the development of, implementation of and advising upon global regulatory strategies for Pharming products in development as well as marketed. This individual will manage regulatory filings and submissions through all phases of development as well as post-approval across global markets. The incumbent will provide strategic regulatory oversight for designated projects ensuring that the latest global Health Authority requirements and standards are met. The Manager, GRA Strategy will also be responsible for preparing regulatory assessment and research on regulatory precedence, to evaluate submission strategies. Areas of responsibility: Responsible for assisting in the development of global product regulatory strategies for products. Develops regulatory content and timelines aligned to company strategic goals including key regulatory milestones and activities. Acts as regulatory representative on cross-functional teams to provide guidance and recommendations on regulatory strategy. May act as interface with Health Authorities. Identifies, assesses, and assists in the mitigation of regulatory risks. Monitors, collects, analyzes, interprets, and disseminates general regulatory affairs information to relevant stakeholders. Reviews development data to ensure alignment with regulatory requirements. Contributes to submissions including Investigational New Drug Applications (INDs), Clinical Trial Applications (CTAs), regulatory meeting documents, registration filings, and supplements/amendments thereof. Coordinates with Regulatory Operations team to ensure timely and accurate submissions to Health Authorities. Demonstrates understanding of regulatory requirements in the pharmaceutical industry and healthcare environment, including policy trends. Uses knowledge of regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals. Excellent oral and written communication skills are a must, as are superior planning skills. The candidate should be detailed-oriented, self motivated, and be comfortable with broad responsibilities in a fast-paced environment. Your profile: Education: Bachelors degree in a life sciences or technical field from an accredited university; advanced degree preferred. RAC certification preferred. Additional training and knowledge: In depth knowledge of Global Health Authority requirements for pharmaceuticals and biologics. Experience: A minimum of five (5) years related experience in Global Regulatory Affairs. Rare disease or specialty pharmaceutical experience preferred. Excellent verbal and written communication skills as well as strong interpersonal skills and tactful negotiation skills. Legal compliance: Ensure that legal compliance is an essential aspect of all department operations. Understand the legal and regulatory frameworks that govern operations of the department and ensure that the company has effective personnel and procedures to meet the requirements. Know the department’s vendor relationships, scope of services provided by each vendor, and legal restrictions applicable to each. Provide for procedure and guidance development, training, monitoring and reporting to ensure internal controls of company operations and vendor controls of vendor operations ensure adherence to legal requirements. Who we are We’re built on a simple belief: people living with rare diseases deserve more. Pharming is a global biotechnology company taking on some of the toughest rare disease challenges. We develop and commercialize innovative therapies for rare and ultra-rare immunological and genetic diseases with significant unmet need, where our scientific and commercial expertise, long-term commitment, and real partnership can help advance care. We put patients at the heart of our work. Their insights, along with those of caregivers, clinicians, scientists, and partners, shape our strategy, guide our decisions, and help turn science into meaningful progress. We keep it simple, act with urgency, and get it done — expanding access to approved therapies, advancing high-value pipeline programs, and building a leading global rare disease company. Our vision is simple: a world where people living with rare diseases don’t wait for progress or care. Together with the communities who inspire us, we’re opening new possibilities — proving that breakthroughs aren’t just discovered. They’re created together. Ready to make a difference? Join us. What it’s like to work here At Pharming, every role helps move rare disease therapies closer to the people who need them. We make it happen together, across teams, disciplines, and borders, because breakthroughs don’t happen in silos. Rare diseases are complex, and meaningful progress takes people who ask better questions, challenge each other, and turn insight into action. Here, you won’t work on the sidelines. Pharming is a place for builders, problem-solvers, and bold thinkers who move with urgency, take ownership, and stay focused on what matters most: improving the lives of people living with rare diseases. Advancing rare disease care isn’t the work of one team or one leader. It’s all of us, building what’s next together. Apply now » Find similar jobs: Alle vacatures, All jobs Opens in a new tab. Cookie Consent Manager When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. 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