Piramal Pharma Executive Regulatory Affairs Job Opening
Piramal Pharma Executive Regulatory Affairs Job Opening. Interested and eligible candidates may apply. M Pharma job opening 2021. Piramal Ltd pharma job opening 2021. Check out all the details on the same below:
Name of Job: Executive Regulatory Affairs
Job ID: 210000UO
Primary Location: India-Maharashtra-Mumbai
Work Locations: Kurla Project : Piramal Agastya, PRL Agastya Pvt Ltd., LBS Marg, Kamani Junction, Near Phoenix Mall, Kurla (West) Mumbai 400070
Job: Regulatory Affairs
Organization: Critical Care
Qualifications:
- B Pharm / M Pharm / M Sc. degree in a related field.
- 2 to 5 years’ experience in regulatory affairs preferred, supporting LATAM/ US region and/or ROW region
EXPERIENCE:
Minimum 2 to 3 years relevant experience in handling Europe market. Over all total experience in Regulatory of 3-5 years
JOB OVERVIEW:
To handle Regulatory filings for Europe with minimal supervision
KEY STAKEHOLDERS: INTERNAL
Country manager, Plant, QA , Artwork department, Supply Chain, PV
KEY STAKEHOLDERS: EXTERNAL
Health Authorities, Distributors
REPORTING STRUCTURE:
Role reports to: Manager, Regulatory Affairs
Positions that report into this role: Nil
KEY ROLES/RESPONSIBILITIES
- Under the guidance of the Team Leader, this person should be able:
- To submit the product registration dossier of assigned products to targeted countries in Europe as per eCTD requirements.
- To file all the required variations and Renewals of assigned products in line with guidelines and checklists as per the plan.
- To respond to queries received from regulatory agencies, business unit or other stake holders by ensuring complete and accurate information is provided within predefined timelines.
- To review product labeling updates in EU.
- To maintenance of various data bases in timely manner.
- To update himself/herself with the relevant current EMEA, National and ICH guidance’s and requirements.
- To provide required support to Pharmacovigilance team as and when required
- To ensure support in execution of any projects assigned as per business need.
Soft skills:
- Good communication skills both spoken and written English
- Should be well versed with using excel sheets, Power Point etc.
- Ready to take challenges in work
- Ready to move to different locations for work as and when required
- Will need to do coordination intra and inter department and across sites globally
- Should be good at review of documents and should have good technical knowledge
- Should be able to do multi-tasking
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