Teva Pharmaceuticals Released Job Openings On 23/07/2022.Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.Application form link provided at the end of post.
Teva Pharmaceuticals Recruiting B.Pharm/M.Pharm graduate with 01-03+ years of Experience for Regulatory Affairs Associate Position.Complete Details for the Regulatory Affairs Associate as follows.
Important Details :
- Location : Navi Mumbai
- No of Vacancies:03
- Details of Salary: NA
- Opening date for online Application: 23/07/2022
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Job Description/Skills Required
With minimal guidance, lead and manage applications through the regulatory approval process for timely approvals.Responsible for preparation, submission and change management of original ANDS, related correspondence to Health.Canada and applicable post approval activities. Work collaboratively with other functional areas and when required.represent the regulatory affairs function through interactive communications with various internal and external stake holders. Communicate effectively and promptly to keep the management informed of any regulatory issues that affect assigned products/projects. Work in a professional manner and be accountable for assigned tasks and departmental goals. As needed, engage in self and collaborative learnings to strengthen essential competencies and to understand and implement any changing regulatory requirements.
Essential Duties & Responsibilities:
- • Perform all regulatory activities for assigned projects including review, dossier compilation, quality file preparation,
- as well as preparation of responses to Health Canadas deficiency letters in cooperation with other business
- • Working closely with management, initiate regulatory strategy on CMC issues throughout the drug development
- process, submission as well as readiness for product launch
- • Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is
- met as agreed in timely manner
- • Responsible for evaluating change controls for regulatory filing assessments in accordance to guidance documents.
- Subsequently prepare and ensure timely post approval regulatory activities, as applicable
- • Keep current with the Teva work procedures, Health Canada Regulations/ Guidance as well as ICH regulations
- • Ensures compliance with all Company policies and procedures, including safety rules and regulations
- • Other projects and duties as required/assigned