Manager, Regulatory Affairs
- Job Title
- Manager, Regulatory Affairs
- Job ID
- 27740303
- Work From Home
- Yes
- Work Remote
- Yes
- Work Hybrid
- Yes
- Location
- Chicago, IL, 60606 Work From Home Remote Hybrid
- Other Location
- Description
-
Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus’ current focus is on the therapeutic areas of hematology, oncology, auto-immune diseases, and allergy.
Position Overview
The Manager, Regulatory Affairs, is responsible for leading and managing all regulatory activities related to both new and existing products, ensuring they meet local, regional, and global compliance requirements in alignment with company policies. This hands-on role involves the strategic planning and execution of regulatory submissions, including pre-clinical, clinical trial, and marketing applications, to secure timely approvals. The Regulatory Affairs Manager will provide expert guidance to translate complex regulatory requirements into actionable and practical strategies. Additionally, this position will manage interactions with regulatory agencies and ensure the development and continuous improvement of the regulatory function to support the company's business goals. This is a hands-on role with opportunity to partner across all levels of our small and entrepreneurial organization.
Position Responsibilities- Strategic Leadership: Develop and implement comprehensive regulatory strategies to ensure timely submissions and approvals of all required regulatory documentation, including clinical trial applications, marketing authorizations, and post-market surveillance.
- Regulatory Compliance: Ensure compliance with all local, regional, and international regulatory requirements, including the maintenance and continuous updating of relevant regulatory systems and databases.
- Stakeholder Management: Build and maintain strong relationships with regulatory authorities, government agencies, and industry bodies to effectively advocate for the company’s interests.
- Regulatory Intelligence: Monitor and analyze regulatory trends and changes, providing actionable insights and recommendations to senior management to proactively address potential impacts on the business.
- Regulatory Documentation: Oversee the preparation, review, and submission of high-quality, scientifically sound regulatory documents, ensuring alignment with both regulatory expectations and internal standards.
- Cross-Functional Collaboration: Collaborate with internal departments such as R&D, legal, and quality assurance to ensure seamless integration of regulatory requirements into the overall product development lifecycle.
- Crisis Management: Provide expert guidance during regulatory inspections and audits, ensuring the company is well-prepared to address any regulatory challenges or inquiries.
- Other Duties: Perform other related responsibilities as required to support the efficient functioning of the regulatory affairs department.
- Educational Background: Bachelor’s degree in Life Sciences, Pharmacy, or a related field. An advanced degree (e.g., Master’s, Ph.D.) in a relevant discipline is highly preferred.
- Industry Experience: Minimum of 7 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry. Experience with biologics and advanced therapies is highly advantageous.
- Technical Expertise: In-depth knowledge of global regulatory frameworks, including FDA, EMA, and ICH guidelines, as well as a strong understanding of scientific principles relevant to regulatory submissions. RAPS certification a plus.
- Leadership Skills: Strong project management skills and the ability to drive complex regulatory projects to successful completion with minimal supervision.
- Communication Skills: Excellent written and verbal communication skills, with the ability to effectively convey complex regulatory concepts to a variety of stakeholders.
- Regulatory Systems Proficiency: Experience with electronic submission systems (e.g., eCTD) and regulatory information management systems (RIMS) is preferred.
Additional Information
Travel: up to 15%
Location: Remote or Hybrid in Chicago, IL
Salary Range: $130,000 - $145,000
Medexus Pharma is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age, disability or any other characteristic protected by law. We assure you that your opportunity for employment with Medexus Pharma depends solely on your qualifications. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our employees, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at careers@medexus.com to request accommodation.
