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Group Leader – Api–gurgaon
10 – 13 YearsKolkata, Pune, Bengaluru/Bangalore, Hyderabad / Secunderabad, Chennai, Panchkula, Mumbai, Vadodara/Baroda, Visakhapatnam/VizagINR 20,00,000 – 25,00,000 P.A
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Job Description
Reports to : Associate Director, Regulatory Affairs – API
Supervises : Team of Research Associate/Research Scientist
10 – 13 YearsKolkata, Pune, Bengaluru/Bangalore, Hyderabad / Secunderabad, Chennai, Panchkula, Mumbai, Vadodara/Baroda, Visakhapatnam/VizagINR 20,00,000 – 25,00,000 P.A
Position Summary:
Accountabilities:
-Review of Drug Master Files, Registration Dossiers & Technical Data Packages/Open Parts for In-House developed APIs manufactured at In-House API manufacturing sites and contract manufacturing sites for adequacy and completeness prior to submission to regulatory agencies & customers respectively and ensuring their updations
-Review of Regulatory Amendments / Variations for smooth API supplies and responses to regulatory deficiencies for expeditious approval
-Provide Regulatory support to Chemical Research Division, Analytical Department, Chemical manufacturing, Quality Assurance, GMS and Regulatory Affairs-Pharma
Level of Responsibility: Medium
Scope: Global as DMFs/Registration dossiers are filed with various International regulatory Authorities (key countries are US, EU, Canada, Japan, Korea, China, Russia, Brazil, South Africa etc.)
Dimension:
-Successful filing of in-house developed APIs globally to support in-house & API customers ANDAs/MAAs
-Lifecycle management of APIs ensured by filing variations for post-approval changes
Delegation of Responsibility:
In the absence of job holder, responsibility will be delegated to a higher level or a colleague at same level.
Job Profile:
-Review of Drug Master Files/Registration Dossiers, Technical Data Package/Open Parts of DMFs for In-House developed APIs for adequacy and completeness and ensure their updation to meet current regulatory requirements
-Facilitate life cycle management by ensuring timely filing of amendments/variations for post-approval changes including pharmacopoeial compliance for smooth API supplies
-Prepare and review responses to regulatory deficiencies
-Review of TDPs/Open Parts of outsourced APIs to support GMS and Regulatory Affairs-Pharma in connection with Drug products filings for Regulatory adequacy
-To provide regulatory support as well as to coordinate with Chemical Research Division, Analytical Department and Manufacturing locations in generating data as per the requirements of regulatory agencies
-To impart training to colleagues to keep them abreast with current Regulatory requirements/procedures
Assessment and Planning of Work
The work is assigned by Job supervisor based on filing priorities, business requirements and also based on self-planning. Based on work volume, work is further assigned to reportees and need to be supervised to get it completed on time with good quality.
Key Features
-Interaction with Chemical Research Division, Analytical Department and Manufacturing locations to generate data as per current regulatory requirements in a timely manner
-To provide technical information to API customers for development of API Business
-To provide support to Regulatory Affairs-Pharma in their regulatory submissions to secure timely approvals
-To provide technical inputs to GMS for vendor selection and qualification of outsourced APIs/Key Intermediates for regulatory adequacy
Salary: INR 20,00,000 – 25,00,000 P.A
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Regulatory Affairs Manager
Role: Regulatory Affairs Manager
Keyskills:
Quality AssuranceRegulatory AffairsManufacturing QualityContract ManufacturingSouth AfricaAPI ManufacturingChemical ResearchAPIGROUP LEADER – APIbulk drugs
Desired Profile
Education:UG -B.Sc – Any Specialization, Chemistry, B.Pharma – Pharmacy
PG – M.Pharma – Pharmacy, M.Sc – Any Specialization, Chemistry
Doctorate – Any Doctorate – Any Specialization, Doctorate Not Required
Company Profile
302 Lovely Mansion, Somajiguda, Raj Bhavan Road, Hyderabad, Andhra Pradesh – 500082,India
Contact Details:
Recruiter Name:chandu reddy
Telephone:040-33540813
Email :chandrakala.b@2coms.com
Address :302 Lovely Mansion, Somajiguda, Raj Bhavan Road, Hyderabad,Andhra Pradesh,India