About Medisal Pharma: As a proud United Arab Emirates company based in Abu Dhabi, Medisal Pharma is dedicated to excellence in manufacturing high-quality pharmaceutical products to enhance global health by developing and delivering high-quality, affordable medicines. With a strong emphasis on innovation, research, and excellence, we aim to make a significant impact on healthcare in Germany and across Europe. To support our expanding international operations, we are looking to hire a skilled Regulatory Manager to oversee our regulatory affairs and ensure compliance in the Germany. Why Join Medisal Pharma: Innovative Environment: Work in a cutting-edge environment that encourages creativity and the adoption of new ideas to drive healthcare solutions. Career Advancement: Benefit from continuous learning and professional development opportunities within a rapidly expanding company. Global Impact: Engage in projects that have a tangible effect on patient health both locally and internationally. Collaborative Culture: Be part of a supportive workplace that values teamwork, diversity, and mutual respect. Job Summary: We are seeking an experienced and highly motivated Senior Regulatory Affairs Specialist to join our team in Berlin. The successful candidate will play a pivotal role in ensuring that Medisal Pharma's products comply with all regulatory requirements in Germany and support our expansion across the European Union. This role involves strategic regulatory planning, managing submissions, monitoring compliance, and collaborating with cross-functional teams to drive product development and commercialization. Key Responsibilities: Regulatory Strategy and Planning: Develop and implement effective regulatory strategies to expedite product approvals and market launches in Germany and the EU. Provide regulatory input during the product development stages to ensure compliance and optimize timelines. Regulatory Submissions and Approvals: Prepare, compile, and submit high-quality regulatory dossiers for new product registrations, renewals, and variations to the Federal Institute for Drugs and Medical Devices (BfArM) and the European Medicines Agency (EMA). Manage responses to regulatory inquiries and deficiencies promptly to facilitate approvals. Compliance Monitoring: Stay updated on changes in German and EU regulations, guidelines, and standards. Assess the impact of regulatory changes on company processes and products; implement necessary adjustments. Cross-Functional Collaboration: Collaborate with R&D, Quality Assurance, Manufacturing, Supply Chain, and Marketing teams to gather required documentation and ensure regulatory compliance throughout the product lifecycle. Participate in project teams to provide regulatory guidance and support decision-making processes. Regulatory Intelligence and Advocacy: Engage with industry associations and regulatory agencies to influence policy development and stay informed about industry trends. Represent Medisal Pharma at regulatory meetings, workshops, and conferences. Documentation and Record Management: Maintain comprehensive and organized regulatory files and databases. Ensure all regulatory documents are accurate, up-to-date, and accessible for audits and inspections. Training and Development: Mentor and train junior regulatory staff and other team members on regulatory requirements and best practices. Promote a culture of compliance and continuous improvement within the organization. Risk Management: Identify potential regulatory risks in projects and propose mitigation strategies. Conduct internal audits to ensure adherence to regulatory standards and company policies. Qualifications: Education: Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related field. A Master's degree or certification in Regulatory Affairs is highly preferred. Must be a registered Pharmacist in Germany. Experience: Minimum of 5 years of progressive experience in regulatory affairs within the pharmaceutical industry. Proven track record of successful product registrations and regulatory project management in Germany and the EU. Experience with Centralized, Decentralized, and Mutual Recognition Procedures is an advantage. Knowledge and Skills: In-depth understanding of German and European pharmaceutical regulations, including AMG, AMWHV, and relevant EMA guidelines. Strong analytical skills with the ability to interpret complex regulatory documents and scientific data. Excellent project management skills, including planning, prioritization, and execution. Proficiency in electronic submission platforms like eCTD and regulatory information management systems. Exceptional communication skills in German and English, both written and oral. Personal Attributes: High level of integrity, professionalism, and ethical judgment. Detail-oriented with strong organizational skills. Ability to work independently and collaboratively within multidisciplinary teams. Adaptable to changing priorities and able to perform under pressure. What We Offer: Competitive Compensation Package: Attractive salary commensurate with qualifications and experience. Annual performance bonuses and incentives. Comprehensive Benefits: Health insurance and wellness programs. Pension plan with company contributions. Generous paid time off, including vacation, sick leave, and public holidays. Professional Growth Opportunities: Support for continuing education, certifications, and professional memberships. Access to industry conferences, seminars, and networking events. Clear career progression pathways and leadership development programs. Work-Life Balance and Well-being: Flexible working hours and opportunities for remote work. Employee wellness programs, including fitness memberships and health screenings. Counseling and support services through our Employee Assistance Program. Inclusive and Collaborative Work Environment: Commitment to diversity, equity, and inclusion in the workplace. Regular team-building activities and company-sponsored events. Open communication channels with management and leadership. How to Apply: If you are ready to advance your career and contribute to a company that is making a real difference in healthcare, we invite you to apply. Please send your updated resume and a compelling cover letter detailing your relevant experience and why you are an excellent fit for this role to careersmedisalpharma.com. Use the subject line: "Application for Senior Regulatory Affairs Specialist, GERMANY– [Your Full Name]". Join Our Mission at Medisal Pharma: Embark on a rewarding career where your expertise and passion for regulatory affairs can make a tangible impact on global health. At Medisal Pharma, we believe that our employees are our greatest asset, and together, we can achieve extraordinary outcomes. We look forward to welcoming you to our team For more information about Medisal Pharma and our commitment to innovation and excellence, visit our website at www.medisalpharma.com .