TalentEdge

Regulatory Affairs Compliance Manager (remote working)

Job Location:  Mumbai City
Job Description:  SkillSet: " internal audit", " pharmaceutical manufacturing", " compliance support", "regulatory affairs", compliance.
Job Opening Details back to list Reference Code: ReguCompMgr0321Mumba Job Title: Regulatory Affairs Compliance Manager (remote working)* Category: Pharmaceuticals, Hospitals / CRO, Bio Technology Life Science Job Description: About company:
Fast-growing Pharma company having its offices in India, UK, Australia, Middle East Europe
*Job title: Regulatory Affairs Compliance Manager (remote working)*
*Job location: Mumbai*
Educational qualification: Bachelor s degree is required. Scientific/health field with relevant work experience.
Experience :-
Generally, has at least 10 to 15 years of related experience within a pharmaceutical company, CRO, CMO or similar organization.
A sound understanding of pharmaceutical manufacturing practices with 5 years experience in this field.
A sound understanding of process validation.
An understanding of the pharmaceutical regulatory system.
A sound understanding of regulatory compliance.
Experience in line management and working cross-functionally
Experience in establishing processes and systems relevant to the management of master production records.
Generally, has at least 10 years of related experience within a pharmaceutical company, CRO, CMO or similar organization.
A sound understanding of pharmaceutical manufacturing practices with 5 years experience in this field.
A sound understanding of process validation.
An understanding of the pharmaceutical regulatory system.
MAIN ACCOUNTABILITIES
Providing regulatory compliance support to 3rd party manufacturing sites producing ATNAHS products.
Review and/or approval of master manufacturing documentation.
Design of process validation strategy and review of protocols.
Support Technical Operations in overseeing all process validations relating to ATNAHS 3rd party manufactured and licenced products, providing timely review and approval as necessary.
Work with the regulatory strategist to define the necessary licence variations ahead of the validation plan.
To provide timely and accurate review of master production records testing specifications and analytical methodology in accordance with the registered details. and completed batch records for validation batches from 3rd party manufacturers required for technical transfer related submissions.
Communicate compliance issues and mitigation plans relating to 3rd party manufacturers to all relevant departments.
Co-ordinating activities of the of the regulatory compliance group to ensure adequate and timely support to ATNAHS s regional markets.
Responsible for the maintenance and approval of master manufacturing documentation, testing specifications and analytical methodology from 3rd party manufacturers.
Support the maintenance and authoring of internal documentation summarising the key licencing details, Master Production Specifications (MPS).
Summarise the key registered details to provide a working business document and increase visibility to the operations teams
Review supply chain maps to ensure these align with the registered sites of activities.
Skills :-
A sound understanding of cGMP
Proven ability to independently resolve problems.
Highly collaborative with cross-functional teams in order to ensure business objectives are met.
Strong knowledge of MS Word, Excel, PowerPoint, Project and Outlook.
Ability to work independently, take initiative and complete tasks to deadlines.
CTC : (depends on current CTC, relevant work experience qualification) Key Skills: MS Word, Excel, PowerPoint, Project and Outlook., Location: Mumbai Required Experience: 10-15 yrs Positions: 1 Contact Person: Hitesh Vaghela Qualification: Any Graduate
,
Functional Area:  Finance / Accounts / Tax
Experience:  10 - 15 years
Qualification:  ("Other in any field")
Salary:  12 Lakh to 20 Lakh INR
 
TalentEdge
Job Ad publication date: 14 May 2021  

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