*Manager, Regulatory Affairs

We are seeking a highly motivated and experienced Manager of Regulatory Affairs to join our team at Teva Pharmaceutical USA. As a global leader in the pharmaceutical industry, we are dedicated to improving the lives of our patients through the development and distribution of innovative and high-quality medications. The ideal candidate for this position will possess a strong background in regulatory affairs, excellent communication skills, and a passion for driving regulatory compliance. If you are looking for a challenging and rewarding opportunity to make a difference in the healthcare industry, we encourage you to apply.

1. Develop and implement strategies to ensure compliance with all regulatory requirements at both the national and international levels.
2. Monitor and interpret changes in regulatory policies and guidelines to ensure timely and accurate implementation within the organization.
3. Collaborate with cross-functional teams to ensure all regulatory requirements are met in the development, manufacturing, and distribution of pharmaceutical products.
4. Prepare and submit regulatory submissions, including new drug applications, amendments, and annual reports, to regulatory authorities.
5. Review and approve labeling, packaging, and advertising materials for compliance with regulatory requirements.
6. Serve as the primary point of contact for regulatory agencies and communicate effectively to address any inquiries or concerns.
7. Conduct internal audits to assess compliance with regulatory requirements and recommend corrective actions as needed.
8. Train and educate employees on regulatory requirements and changes to ensure understanding and adherence.
9. Maintain accurate and up-to-date records and documentation in compliance with regulatory standards.
10. Participate in industry conferences, seminars, and workshops to stay informed about current regulatory trends and best practices.
11. Drive continuous improvement initiatives to streamline processes and ensure efficiency in regulatory compliance.
12. Collaborate with the Quality Assurance team to ensure compliance with Good Manufacturing Practices (GMPs) and other quality standards.
13. Provide guidance and support to product development teams to ensure regulatory requirements are considered in the early stages of product development.
14. Stay abreast of competitive landscape and provide insights and recommendations to senior management on potential impacts to regulatory strategies.
15. Represent the company in regulatory matters and maintain positive relationships with regulatory authorities.

According to JobzMall, the average salary range for a *Manager, Regulatory Affairs in Parsippany-Troy Hills, NJ, USA is between $118,000 and $149,000 per year. This can vary depending on factors such as years of experience, education, and specific job responsibilities.

Teva Pharmaceutical Industries Ltd., also known as Teva Pharmaceuticals, is an American Israeli pharmaceutical company with dual headquarters in Petah Tikva, Israel and Parsippany, New Jersey, U.S. Teva Pharmaceutical Industries Ltd. engages in the provision of pharmaceutical services. It operates through the following business divisions: Generic, Specialty Medicine, and Over-the-Counter (OTC).