MS in Regulatory Affairs

Postgraduate Entry Requirements

Academic Qualifications: Applicants for postgraduate programs typically require a minimum academic achievement of 70% or above in their bachelor's degree.

English Language Proficiency:

• IELTS: Overall band score of  6.5 with a minimum of 6.0 in each component.
• TOEFL: Overall score of 79 or higher.
• PTE: Overall score of 53 or higher.
• DET (Duolingo English Test): Minimum score of 105.

Northeastern University in Boston offers a range of scholarship opportunities for international students to help alleviate the financial burden of studying in the United States. These scholarships are designed to support academically talented students from around the world, promoting diversity and fostering an inclusive campus environment.

Merit-Based Scholarships: Northeastern University provides merit-based scholarships to international students based on academic excellence and achievements. These scholarships are awarded during the admissions process and are highly competitive. The amount and criteria for these scholarships may vary, but they aim to recognize students who demonstrate exceptional academic performance, leadership potential, and a strong their chosen field of study.

Northeastern International Scholars Program: This prestigious program offers scholarships to outstanding international students who exhibit leadership, academic excellence, and a desire to contribute to the global community. The Northeastern International Scholars Program provides both financial support and opportunities for personal growth through networking events, leadership training, and involvement in community service initiatives.

Need-Based Financial Aid: Although Northeastern University does not offer need-based financial aid to international students, there are still many merit-based scholarships available that can significantly reduce tuition costs. However, international students are encouraged to seek external scholarships or funding from their home country to help cover the remaining costs.

External Scholarships and Funding: In addition to institutional scholarships, international students at Northeastern University can explore a variety of external scholarship opportunities from governments, foundations, and organizations in their home countries. Many international students receive funding from these sources to support their education at Northeastern.

MS in Regulatory Affairs program at Northeastern University provides graduates with a solid foundation to pursue diverse roles in industries such as pharmaceuticals, biotechnology, medical devices, and healthcare.

Regulatory Affairs Manager: Graduates of the MS in Regulatory Affairs program can pursue careers as Regulatory Affairs Managers. In this role, they oversee the regulatory compliance of pharmaceutical, biotechnology, or medical device companies. They manage the regulatory processes for product approval, ensuring that products meet federal and international regulatory requirements. This role involves preparing and submitting regulatory documents, conducting regulatory strategy planning, and collaborating with other departments to facilitate product development.

Regulatory Affairs Specialist: A career as a Regulatory Affairs Specialist involves supporting regulatory affairs teams by managing regulatory documentation, ensuring compliance with regulations, and tracking regulatory changes. Graduates in this role may be responsible for preparing submission documents, interacting with regulatory agencies, and coordinating product approvals. This position is suitable for those interested in hands-on regulatory processes and attention to detail.

Clinical Regulatory Affairs Manager: In the pharmaceutical and biotechnology industries, graduates can take on roles as Clinical Regulatory Affairs Managers. These professionals are responsible for ensuring that clinical trials and studies comply with regulatory requirements, including the submission of clinical trial applications and new drug applications. They work closely with clinical research teams to ensure adherence to regulatory standards and timelines.

Quality Assurance (QA) Specialist: With a background in regulatory affairs, graduates can become QA Specialists in pharmaceutical or medical device companies. QA specialists are responsible for ensuring that products meet quality and regulatory standards, focusing on the validation and compliance of manufacturing processes. They conduct audits, inspections, and ensure that the company’s products adhere to Good Manufacturing Practices (GMP).

Medical Device Regulatory Affairs Specialist: Graduates of the MS in Regulatory Affairs program may specialize in medical device regulation. As Medical Device Regulatory Affairs Specialists, they work to ensure that medical devices comply with regulatory standards set by authorities like the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency). They are responsible for filing product submissions, managing device approval processes, and keeping track of changing regulatory standards in the medical device industry.

Regulatory Compliance Officer: A Regulatory Compliance Officer ensures that all company operations and products comply with the appropriate regulatory requirements. This role involves monitoring regulatory changes, ensuring company-wide compliance, conducting audits, and training staff on regulatory matters. Graduates may find roles in regulatory affairs departments, ensuring organizations stay compliant in all markets where they operate.

Pharmaceutical Regulatory Affairs Expert: Graduates with a focus on pharmaceuticals can become Pharmaceutical Regulatory Affairs Experts, guiding companies through the complex regulatory processes involved in the development, approval, and marketing of drugs. They are responsible for submitting regulatory filings and working with the FDA or other agencies to ensure timely approval of drug products.

Biotech Regulatory Affairs Consultant: As a consultant, graduates can provide expert advice on regulatory strategy and compliance. Biotech Regulatory Affairs Consultants offer services to companies that need guidance in navigating the regulatory landscape, especially in areas like clinical trials, product approvals, and global compliance. They work with biotech firms to help them prepare for product launches and regulatory submissions.

Government Regulatory Agencies (FDA, EMA, etc.): Graduates of the MS in Regulatory Affairs program are well-prepared for roles within government regulatory agencies such as the U.S. FDA or the European Medicines Agency (EMA). These roles involve evaluating regulatory submissions, monitoring drug safety, and ensuring that products meet the necessary standards before they are approved for the market.

Research and Development (R&D) Regulatory Specialist: In the R&D sector, graduates can serve as Regulatory Specialists, helping research teams comply with regulatory guidelines as they develop new products, especially in biotechnology and pharmaceuticals. They ensure that the development process aligns with regulatory expectations from initial research stages through to market launch.

Regulatory Affairs Director: For those with extensive experience, the role of Regulatory Affairs Director involves overseeing an entire regulatory affairs department. This leadership role is responsible for developing the regulatory strategy for the company, managing regulatory staff, and liaising with senior executives to ensure that products meet all regulatory requirements. Directors in regulatory affairs play a key role in shaping the company’s strategy and ensuring compliance across all departments.

Clinical Trial Regulatory Affairs Coordinator: Graduates can also work as Clinical Trial Regulatory Affairs Coordinators, overseeing the regulatory compliance of clinical trials. They manage the submission of clinical trial applications and assist in meeting the necessary regulatory requirements throughout the trial process, ensuring compliance with local and international regulations governing clinical research.