
Regulatory Affairs Co-op
Welcome to Merck & Co! We are a global pharmaceutical company dedicated to improving the lives of people around the world. We are currently seeking a Regulatory Affairs Co-op to join our team and help us in our mission of developing and delivering innovative medicines and vaccines. As a co-op, you will have the opportunity to gain valuable hands-on experience in the fast-paced and ever-evolving field of regulatory affairs. We are looking for a highly motivated and detail-oriented individual with a strong interest in the pharmaceutical industry. If you are a team player with excellent communication and organizational skills, we encourage you to apply for this exciting opportunity.
- Assist the Regulatory Affairs team in various tasks related to the development and delivery of pharmaceutical products.
- Conduct research and analysis on regulatory guidelines and requirements to ensure compliance with local and international laws.
- Help prepare and submit regulatory documents, such as applications, reports, and dossiers, to relevant authorities.
- Participate in meetings and interactions with regulatory agencies to provide support and address any inquiries or concerns.
- Collaborate with cross-functional teams, including R&D, marketing, and quality assurance, to gather necessary information for regulatory submissions.
- Keep track of regulatory timelines and deadlines to ensure timely submission of documents and compliance with regulatory requirements.
- Assist in the review and approval of labeling, packaging, and promotional materials to ensure regulatory compliance.
- Maintain accurate and organized records of all regulatory documents and submissions.
- Stay updated on changes in regulatory guidelines and communicate any relevant updates to the team.
- Contribute to the development and implementation of processes and procedures to improve regulatory compliance and efficiency.
- Demonstrate a strong understanding of the pharmaceutical industry and its regulations and apply this knowledge to support the team's objectives.
- Adhere to all company policies, procedures, and safety standards.
- Collaborate with other co-ops and team members to complete assigned projects and tasks.
- Communicate effectively with team members and managers to provide progress updates and seek guidance when needed.
- Take initiative to learn and take on new responsibilities as directed by the Regulatory Affairs team.
Excellent Communication And Interpersonal Skills.
Bachelor's Degree In A Relevant Field Such As Pharmaceutical Sciences, Life Sciences, Or Regulatory Affairs.
Strong Understanding Of Fda Regulations And Guidelines.
Proficient In Microsoft Office And Other Relevant Software.
Prior Experience Or Coursework In Regulatory Affairs Or Related Field.
Quality Assurance
Project Management
Global regulations
Drug development
Risk assessment
Regulatory compliance
FDA regulations
Clinical Trials
Medical
Product Registration
Labeling Requirements
Submission Process
Communication
Conflict Resolution
Leadership
Time management
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
Empathy
According to JobzMall, the average salary range for a Regulatory Affairs Co-op in Rahway, NJ 07065, USA is approximately $22-$30 per hour. This may vary depending on the specific company and industry.
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Merck & Co., Inc., d.b.a. Merck Sharp & Dohme outside the United States and Canada, is an American multinational pharmaceutical company and one of the largest pharmaceutical companies in the world. Merck & Co., Inc. engages in the provision of health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products. It operates through the following segments: Pharmaceutical, Animal Health, Alliances and Healthcare Services. The Pharmaceutical segment includes human health pharmaceutical and vaccine products marketed either directly by the company or through joint ventures.

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