GlaxoSmithKline Hiring 2022 Bachelor's degree/ Masters degree for Regulatory Specialist III - MSR Coordination At Bengaluru, India . GlaxoSmithKline Notification full details below..Interested and eligible candidates can Apply Now.
- Vacancy details:
- Post Name: Regulatory Specialist III - MSR Coordination
- Qualification: Bachelor's degree/ Masters degree
- Experienced: 0 to 6 years
- Openings:NA
- Salary:NA
Job Description: GlaxoSmithKline Hiring For Regulatory Specialist III - MSR Coordination !
- Important Details :
- Location: Bengaluru, India
- Note: you should disregard the same and inform us by emailing askus@gsk.com
- Post of date: 15/06/2022
- Selection Process: The selection will be on the basis of Interview.
Roles and Responsibilities
Job Purpose:
- Provides support for GRA regulatory delivery activities (e.g., Variations, Product Expansion dossiers, Renewals and regional projects) of assigned projects with management input.
- Supports Global Regulatory by authoring and coordinating appropriate MSR packages for global regulatory submissions with appropriate guidance from supervisor, as necessary.
- May have training responsibilities for new staff on established departmental processes.
Key Responsibilities:
- With minimal input from manager, executes agreed dossier strategy related to MSR packages
- Liaise with MSR suppliers & customers (GMS, External Supply QA, LOCs) to obtain documentation in a timely manner.
- With minimal input from manager, manages multiple project assignments supporting Variations, Product Expansion dossiers, Renewals and regional projects simultaneously; MSR packages/documents will range in complexity
- With minimal input from manager, completes data assessment to ensure MSR package is fit for purpose, identifies risks associated with submission data and MSR packages.
- Communicates with line manager to identify issues that have business impact.
- May have responsibilities for reviewing work of peers and may identify improvement opportunities for Regulatory processes, policies and systems.
- Developing an understanding of regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical and vaccines products
- Understands internal/external Regulatory environment
- Actively builds an organizational network.
- Communicates across GSK, with minimal input from manager regarding projects and new requirements impacting MSR deliverables
Knowledge/ Education / Previous Experience Required:
A. Educational Background :
1. Minimum Level of Education - Bachelor's degree in biological or healthcare science qualification or experience within Regulatory Affairs in the Drug development environment
Area of Specialization - Chemistry, pharmacy or other related science or technical bachelors degree.
Why is this Level of Education Required - Appropriate for the role
2. Preferred Level of Education - Masters degree or higher in biological or healthcare science
Area of Specialization - Regulatory, Pharmaceutics, or other related science or regulatory affairs. Project Management, Communication
Why is this Level of Education Preferred - Appropriate for a scientific environment
B. Job-Related Experience:
Minimum Level of Job-Related Experience required
- Minimum 0 - 6 years of relevant experience
- Demonstrated ability to proactively manage workload, timelines and identify priorities. Build relationships with relevant internal functions.
- Proven ability to work on multiple projects simultaneously.
- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- Global/ EMAP Regulatory submission experience - Knowledge of regulatory agency guidelines
- Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
- Excellent written and verbal communication skills and ability to present information in a clear and concise manner
- Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience
- Ability to build effective working relationships and work in a matrix environment effectively
- Ability to think flexibly in order to meet constantly shifting priorities and timelines.
Why is this Level of Experience Required - These basic skills are fundamental to delivery of work in MSR team
C. Other Job-Related Skills/Background
- Excellent attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
- Demonstrated ability to think flexibly in order to meet constantly shifting priorities and timelines.
- Demonstrates the following behaviors: Customer focus and Enable and drive change
How to Apply :
Step 1: Click on below link and you will be redirected to Career Page of Recruiting Company or Career portal.
Step 2. Register on Career Page of the Company or Career Portal by giving log in credentials and other personal or education details .
Step 3.Upon successful registration .User need to log in with credentials.
Step 4.Once logged in, User need to fill the all relevant personal ,educational , Work experience details ,attach resume and submit application form.
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