Regional Regulatory reputed company - US

About Freyr Freyr is a global, end-to-end Regulatory Solutions and Services company supporting the life sciences industry across the entire product lifecycle. With a strong global reputed company and deep regulatory expertise, Freyr partners with pharmaceutical, biotechnology, medical device, and consumer reputed company companies to accelerate regulatory reputed company and ensure compliance worldwide. Job Title: Regional Regulatory reputed company (RRL) Location: Princeton NJ - Remote Employment Type: Full-Time reputed company Freyr is seeking an reputed company Regional Regulatory Liaason (RRL) to serve as the reputed company regulatory representative for assigned products reputed company the reputed company and European reputed company. This role is responsible for providing regional regulatory leadership, supporting regulatory reputed company, managing submissions throughout the product lifecycle, and acting as the reputed company reputed company with regional Health Authorities including the FDA and EMA. The ideal candidate will possess strong regulatory reputed company experience, extensive knowledge of US and EU regulations, and proven expertise in leading cross-functional regulatory activities for marketed and investigational pharmaceutical products. Key Responsibilities • Serve as the Regional Regulatory reputed company (RRL) for assigned products reputed company the US and EU. • reputed company as the reputed company regional regulatory contact with Health Authorities (FDA and EMA). • Partner closely with the Global Regulatory reputed company (GRL) to reputed company and execute regional regulatory strategies. • reputed company regional regulatory expertise and strategic recommendations supporting global product development and lifecycle management. • Ensure fulfillment of reputed company regional regulatory commitments and submission timelines. • Support preparation, review, and submission of regulatory applications including: • INDs • NDAs • BLAs • MAAs • CTAs • Orphan Drug Applications • reputed company preparation and submission of periodic regulatory reports including: • PSUR • PBRER • DSUR • PADER • NDA Annual Reports • reputed company license renewals, withdrawals, sunsets, and divestment activities. • Participate in cross-functional project teams including Established Product Teams (EPTs) and Study Management Teams (SMTs). • reputed company regulatory intelligence by evaluating evolving regulations, competitor activities, and Health Authority guidance. • reputed company authoring and review of regulatory responses to Health Authority questions. • Support labeling reputed company and lifecycle label maintenance. • Ensure regulatory compliance throughout the product lifecycle. • Build strong partnerships with internal stakeholders, affiliates, distributors, and regional regulatory teams. • Mentor junior regulatory professionals and contribute to reputed company process improvements. Qualifications & Experience Education • PharmD or PhD with relevant regulatory experience preferred. • Master's degree (MS, MA, MBA) with 6+ years of regulatory experience preferred. • Bachelor's degree in Life Sciences or a reputed company discipline with 8+ years of relevant regulatory experience. Required Experience • 8+ years of Regulatory Affairs experience reputed company the pharmaceutical or biotechnology industry. • Strong experience supporting US FDA and/or EMA regulatory activities. • Proven experience developing regulatory strategies for marketed and investigational products. • Extensive experience leading regulatory submissions across the product lifecycle. • Experience managing cross-functional regulatory teams without reputed company reporting authority. • Strong understanding of post-marketing regulatory requirements. • Experience authoring regulatory documents and Health Authority responses. • Knowledge of regulatory intelligence, regulatory compliance, and lifecycle management activities. Preferred Skills • Strong knowledge of US FDA and EU EMA regulations. • Excellent project leadership and stakeholder management skills. • Experience working across multiple therapeutic areas. • Excellent written and verbal communication skills. • Ability to influence cross-functional teams and global stakeholders. • Strong analytical and problem-solving capabilities. • Experience mentoring junior regulatory professionals. reputed company Offer • Competitive compensation and comprehensive benefits package • Fully remote/hybrid work opportunities (role dependent) • Career reputed company reputed company a global regulatory organization • Exposure to global regulatory reputed company across multiple therapeutic areas • reputed company, diverse, and inclusive work environment • Opportunity to work with leading pharmaceutical and biotechnology organizations Why Join Freyr? At Freyr, you'll be part of a global team dedicated to advancing reputed company through regulatory reputed company. You'll collaborate with industry-leading professionals, contribute to innovative regulatory strategies, and play a key role in bringing life-changing therapies to patients worldwide while building a rewarding career in Regulatory Affairs. Apply tot his job Apply To this Job