Dr. Reddys Laboratories is Hiring For Regulatory Affairs Manager and has issued notification to accept Applications. Dr. Reddy€™s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Application form link provided at the end of post. Eligibility for the Regulatory Affairs Manager as follows.
Vacancy summary details :
- Company Name: Dr. Reddys Laboratories
- Location: Hyderabad
- Post Name: Regulatory Affairs Manager
- Qualification: MSc / M.Pharm
- Experience: 8-12 Years
- No of Vacancies: NA
- Details of Salary:NA
- Closing date for online Application : Apply as soon as possible
- Date of examination: NA
- Time and Venue :NA
- Mode of application : online
- Selection Process: Shortlisted candidates may called for selection process ( Personal interview , Group discussion , etc…,)
Job Description/Skills Required:
- Knowledge of the regulatory guidance available with FDA, ICH, EMA, with expertise in ANVISA, other regulatory agencies for APIs and fair understanding of the drug products approval cycle.
- Search & review the regulatory assessment reports (RLD / SBOA/EPAR/other literature evidences) available in regulatory websites or public domain and share the inputs with HPT for fixing the limits for impurities or defining the control strategy based on the maximum daily dosage.
- Must have sufficient chemistry knowledge to evaluate the synthetic schemes and aid in selection of appropriate regulatory starting materials for these complex APIs and define regulatory requirements for the selected starting materials in consultation with their managers
- Participate in the technical discussions with the HPT for defining & finalizing the specifications for starting materials/intermediates/drug substance.
- Ensure GTI evaluation is carried out and necessary control strategies are put in place based on purge study, purge factors and/or routine or non-routine testing of the PGIs at appropriate stages.
- Responsible for communicating the global & region specific regulatory requirements to HPT for a global development.
- Review the documents received from CFTs and ensure quality of the technical reports and DMF.
- Responsible for responding to the regulatory deficiencies with adequate data and within stipulated timeline.
- Co-ordinate with GMO teams Plant documentation needed for DMF preparation/deficiency responses/customer support.
- Stay well-informed of the regulatory procedures and the changing regulatory requirements. Must be aware of QbD principles, ICH guidelines to ensure their applications during product development and preparation of DMF submissions.
- Share the learning from regulatory deficiencies and updated regulatory guidelines with CFTs periodically during the daily meeting to integrate the requirements.
How to Apply :
Step 1: Click on below link and you will be redirected to Career Page of Recruiting Company or Career portal.
Step 2. Register on Career Page of the Company or Career Portal by giving log in credentials and other personal or education details .
Step 3.Upon successful registration .User need to log in with credentials.
Step 4.Once logged in, User need to fill the all relevant personal ,educational , Work experience details ,attach resume and submit application form.