Act as Local Contact Person for Pharmacovigilance for the designated country.
Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables.
Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They provide first class support to their small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field.
Serve as Global Regulatory Lead for the Phase 3 HCM program.
Provide strategic regulatory input and leadership at program governance forums and core team meetings.
Plan, prepare, review, and oversee submissions to regulatory authorities supporting late-stage development and registration readiness.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, they represent an outstanding opportunity for ambitious, mission-driven professionals.
Collaborate with client teams to understand products and create regulatory strategies.
Implement strategies by engaging regulatory authorities and authoring submissions.
Proactively influence the regulatory environment to achieve business goals.
EVERSANA provides next-generation commercialization services to the life sciences industry, serving over 650 clients from biotech startups to established pharmaceutical companies. They have a global team of more than 7,000 employees committed to creating a healthier world by bringing innovative therapies to market and supporting patients.
Own and evolve the company’s product safety and risk management framework.
Proactively identify safety and compliance risks associated with dietary ingredients and formulations.
Translate complex risk and safety topics into clear, actionable guidance.
Nutrafol pioneers clinically tested products for hair growth, supporting people at every step of their hair journey. They target key root causes of hair thinning using a patented blend of standardized vitamins, minerals and natural ingredients. They are recommended by over 7,500 physicians and hair professionals.
Handle new registrations, lifecycle management, and renewals of biologicals, vaccines, and other pharmaceutical products.
Contribute to the preparation and delivery of regulatory submissions from a global and regional perspective.
Prepare and review Marketing Authorization Applications & Variations for multiple regions.
Jobgether is a platform that connects job seekers with employers, leveraging AI to streamline the hiring process. They focus on ensuring fair and efficient candidate evaluation, emphasizing data privacy and objective matching of applicants to roles; their team uses AI tools to support recruitment but makes the final decisions.
Define and execute global CMC regulatory strategies for investigational and marketing applications.
Lead preparation, review, and approval of CMC sections for regulatory submissions.
Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks.
BridgeBio is a biopharmaceutical company focused on discovering, creating, testing and delivering transformative medicines to treat patients who suffer from severe diseases. They employ a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation.