Piramal Pharma Executive Regulatory Affairs Job Opening

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

Apply Online

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