
Regulatory Affairs Intern
At Merck & Co., we are committed to developing innovative pharmaceuticals and improving the lives of patients around the world. To achieve this goal, we are seeking a highly motivated Regulatory Affairs Intern to join our dynamic team. This is a unique opportunity to gain hands-on experience in the fast-paced world of regulatory affairs at one of the leading global biopharmaceutical companies. We are looking for a passionate individual who is eager to learn and make a meaningful impact in the pharmaceutical industry. If you possess strong attention to detail, excellent communication skills, and a desire to contribute to the development and approval of life-saving medicines, we encourage you to apply for this internship.
- Assist in reviewing and compiling regulatory submissions for new and existing pharmaceutical products.
- Conduct research and analysis on regulatory guidelines and requirements to ensure compliance.
- Collaborate with cross-functional teams to support the development and submission of regulatory documents.
- Participate in meetings with regulatory agencies to discuss submission strategies and resolve any issues.
- Maintain accurate and up-to-date records and documentation related to regulatory submissions.
- Support the preparation of reports and presentations for regulatory agencies and internal stakeholders.
- Stay current with industry developments and regulatory changes that may impact the company's products and processes.
- Assist in the review and approval of product labeling and promotional materials to ensure compliance with regulations.
- Work closely with product development teams to ensure timely and efficient regulatory submissions.
- Contribute to the development and implementation of regulatory strategies for new and existing products.
- Communicate effectively with internal teams and external partners to provide updates on project timelines and regulatory requirements.
- Identify potential risks and propose solutions to ensure compliance with regulatory standards.
- Participate in training and development opportunities to enhance knowledge and skills in regulatory affairs.
- Adhere to company policies and procedures, as well as regulatory guidelines, at all times.
- Contribute to a positive and collaborative work environment by sharing ideas and actively participating in team meetings and projects.
Ability To Work Independently And In A Team Environment.
Bachelor's Degree In A Relevant Field Such As Pharmacy, Life Sciences, Or Biomedical Engineering.
Strong Understanding Of Fda Regulations And Guidelines For Drug Development And Approval.
Excellent Communication Skills, Both Written And Verbal.
Previous Experience Or Coursework In Regulatory Affairs Or Related Field (Such As Drug Development, Clinical Trials, Or Quality Assurance).
Project Management
Data Analysis
Technical Writing
Quality Control
Global regulations
Regulatory compliance
Clinical Trials
Regulatory Strategy
Pharmaceutical Regulations
Cross
Labeling Requirements
Fda Submissions
Communication
Conflict Resolution
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
Empathy
According to JobzMall, the average salary range for a Regulatory Affairs Intern in Rahway, NJ 07065, USA is $30,000-$40,000 per year. However, this can vary depending on the specific company, location, and level of experience of the intern. It is important to research and negotiate salary expectations with the employer during the hiring process.
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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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