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Home
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AGM - Regulatory Affairs (Biopharmaceutical) |
| Eligibility : |
UG - B.Pharma - Pharmacy,PG - M.Pharma - Pharmacy |
| Location : |
Delhi |
| State |
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| Designation : |
AGM - Regulatory Affairs (Biopharmaceutical) |
| Details :: |
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The company is a leading Recruitment Process Outsourcing firm, seamlessly integrates with corporate recruitment services model by providing on-site consulting, manpower planning, talent search, staffing, candidate assessments, HR outsourcing and software development as high cost effective solutions to the clients.The company has the flexibility to meet different needs of Recruitment, HR Outsourcing and Staffing services across Industries viz. ITES, Telecom, IT, Media, Infrastructure, Health care, B.F.S.I. (Banking, Financial Services and Insurance), Research, Automobiles & Logistics, Consumer Goods and Life sciences, Retail. With strong presence in Global markets through shared service operations.
Roles & Responsibilities:
Major
To guide, direct, plan, compile, review, respond and strategize quality regulatory submissions to meet the requirement of the concerned authority in Regulated markets- US, EU, Japan, SA & Australia or ROW & domestic markets in the targeted country/ies for the assigned project/product with proper interaction with all the concerned depts in order to secure the approval of new vaccines/drugs and post-approval changes.
To coordinate and conduct due diligence and audits in support of internal/external projects being pursued by the company.
Minor:
To develop rapport with the related international or national approving authorities and maintain the relationship to ensure timely approvals of drugs.
To prepare & review documents including SOPs, specifications, stability protocols, and validation protocols in compliance with cGMP norms.
Accountability:
Planning:
To plan the activities on different proposal and assure adherence by direct reportees.
To plan and prioritize all documentation as per the need of the company.
To plan & prepare related application, dossiers etc as per the required format of a project and ensure submission on time.
To design & prepare different protocols for conducting regulatory bodies.
Organizing:
To interact with R&Ds, manufacturing, QA and the Clinical Research departments etc throughout the development and submission process and to ensure all submission related documents are viewed & all problems are identified and addressed.
To organize proper responses to queries raised by concerned regulatory bodies.
To arrange for re-submission of application based on responses submitted.
To arrange for inserts and other such material as per the direction of concerned approving authority.
To maintain all documents on al the projects for both approved and under process.
Reviewing:
To review documents for regulatory submission including study protocols, study reports, amendments, supplements etc.
To review promotional materials and labeling of assigned projects.
To review and determine the submission strategy required and labeling changes.
Implementing:
To ensure the preparation of protocols, reviews & reports to regulatory organizations for approval as per the requirement.
To ensure timely & effective regulatory input for a high quality documentation so as to achieve rapid & advantageous registration
To ensure that SOPs & cGCP rules & guidelines are being followed.
To disseminate pertinent regulatory information i.e. new guidelines/regulations
Advising:
To suggest on the administration of cGCP procedures to monitor quality, efficiency, uniformity and compliance.
Objectives:
Long Term Objectives:
To ensure that all the new drugs get approval from targeted regulatory organizations on time to avoid loss of opportunity in the market for all the new projects of the organization through timely interventions in providing and corresponding to queries or requests and maintaining good relationships.
Short Term Objectives:
To plan & prepare proactively dossiers for all the running projects and ensures timely submission and getting approval.
People Development:
To share new regulatory guidelines/regulations etc with colleagues.
To advise on any matter related to regulatory affairs and is familiar with the latest regulations, guidelines and trends.
Individual Development:
To self-study related literature and gather information from all available resources, which help in building new skills/competencies & dissemination of such knowledge on rules and regulation of different approving bodies.
To acquire knowledge on recent changes or modification in rules and regulations.
Desired Candidate Profile
Job Specifications:
Qualification:
M. Pharma or M.Sc.-Biotechnology/Microbiology
Soft Skills
Good communication & interpersonal skills.
Strong presentation & analytical skills
Must possess team-building capabilities.
Excellent time management skills.
Technical Skills:
Good knowledge of Protocol drafting procedure
Knowledge of Regulatory rules & regulations.
Knows cGMP requirements and compliant laboratory practices.
Good understanding of manufacturing, QC/QA procedures
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| Last Date : |
2008-01-18 |
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| Keywords: jobs,biotech jobs,biotech career,biotech pharmaceutical jobs,jobs in biotech,biotech sales jobs |
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