About Company
ASTRAZENECA PLC. was established in 1999 as a global biopharmaceutical company headquartered in Cambridge, United Kingdom, AstraZeneca specializes in discover, development and manufacturing of pharmaceutical drugs of various therapeutic domain like oncology, cardiovascular, renal and metabolism (CVRM), respiratory and immunology, and rare diseases and distribute the medicines across the country. AstraZeneca operates in more than 100 countries and employs over 89,000 people around the world. For more details about the company, please visit the official website of https://www.astrazeneca.com/
- DEPARTMENT – Regulatory Affairs
- DESIGNATION – Executive Regulatory Affairs
- DIVISION – Documentation & Submission
- EXPERIENCE – Experienced
What are the job responsibilities of the job responsibilities?
- Accountable for preparing documentation and ensuring that the records are up to date.
- Notify the concerned officials of any changes to the license status.
- Follow all the regional and global regulatory standards, and especially AstraZeneca’s code of conduct, corporate governance, and audit standards.
- Stay aware of the components of essential products like marketing strategy, submission dossiers, regulatory insights, launch timelines, and supply chain planning.
- Engage in the timely execution of activities like observing local testing and legal documentation for new product launches.
- Coordinate with other department teams like Supply Chain, QA, Clinical Operations, and regional and global regulatory affairs officials.
- Handle the import registration, renewal procedures, and production transfer documents to sustain business flow.
- Monitor regulatory compliance during the study life cycle, including protocol amendments and closure activities.
- Observe and timely report the status of all product licenses.
- Performed all the duties assigned by the senior officer.
What is the required educational qualification?
Interested candidates can apply for the position of Executive Regulatory Affairs, Please read the article carefully to get more details about the eligibility criteria for the position.
- Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm)
- Master’s degree in life sciences.
- Minimum 02 years of experience in regulatory affairs.
- Good knowledge of pharmaceutical regulatory guidelines like NDA, MHRA, and FDA guidelines.
What skills and Expertise are required to get the position?
- Regulatory Data Tracking and Documentation Management
- Audit Readiness
- Attention to detail and Critical Thinking Ability
- Good knowledge of regulatory guidelines.
What salary does the company offer for the job role of Regulatory Affairs Executive?
The company has not disclosed the salary figures, but as per the industry standards, job profile, and experience, the candidates can expect a salary of up to INR 40,000/ per month. The exact salary figures will be disclosed after the selection or will be discussed during an interview.
What is the job location?
The Candidates will be recruited for the position of Executive, and the selected candidates will be working in AstraZeneca’s Mumbai-based office.
How to Apply for the Astrazeneca PLC Regulatory Affairs Jobs?
Applicants can read all the details by going through the complete job information and can submit their application online using the direct application link mentioned below.
Direct Application Link: Click Here
