Assistant Manager – Regulatory Affairs

Welcome to AstraZeneca – a global, science-led biopharmaceutical company driven by a passion for improving patients' lives. We are currently seeking a dynamic and highly motivated individual to join our team as an Assistant Manager in the Regulatory Affairs department. As an Assistant Manager, you will play a crucial role in ensuring regulatory compliance and successful product approvals for our innovative medicines. We are looking for someone who is detail-oriented, has a strong understanding of regulatory requirements, and is able to thrive in a fast-paced and ever-changing environment. If you are a self-starter with a passion for making a difference in the healthcare industry, we encourage you to apply for this exciting opportunity.

1. Assist the Regulatory Affairs Manager in developing and implementing regulatory strategies for new and existing products.
2. Conduct thorough research and analysis of regulatory requirements to ensure compliance with local and international regulations.
3. Prepare and submit regulatory submissions, including new drug applications, amendments, and variations.
4. Collaborate with cross-functional teams, including research and development, clinical, and quality assurance, to ensure timely and accurate completion of regulatory activities.
5. Maintain up-to-date knowledge of global regulatory changes and communicate potential impact to relevant stakeholders.
6. Manage and track timelines for regulatory submissions and approvals.
7. Prepare and review documents and reports for regulatory agencies, ensuring accuracy and adherence to established guidelines.
8. Develop and maintain strong relationships with regulatory authorities and participate in meetings and discussions as needed.
9. Ensure all regulatory documentation is maintained in accordance with company policies and procedures.
10. Assist in the creation and maintenance of standard operating procedures and work instructions for the regulatory affairs department.
11. Provide support and guidance to other team members as needed.
12. Contribute to the continuous improvement of regulatory processes and systems.
13. Keep abreast of industry trends and changes in regulations to identify potential risks and opportunities for the company.
14. Represent the company in a professional manner and uphold the company's values and standards.
15. Maintain confidentiality of all sensitive information and adhere to all company and regulatory policies and procedures.

According to JobzMall, the average salary range for a Assistant Manager – Regulatory Affairs in New Delhi, Delhi, India is between ₹1,080,000 to ₹1,800,000 per year. This salary range can vary depending on the specific industry, company size, and experience level of the individual.

AstraZeneca plc is a British-Swedish multinational pharmaceutical and biopharmaceutical company.