GSK Hiring Regulatory Specialist-Apply On Rxhirepro

GSK is a leading global pharmaceutical company headquartered in the United Kingdom. It's one of the largest pharmaceutical companies in the world, known for its research, development, manufacturing, and marketing of pharmaceuticals, vaccines, and consumer healthcare products. GSK operates in many therapeutic areas including respiratory, HIV/AIDS, oncology, and vaccines. They have a significant presence in both developed and developing markets worldwide. Additionally, GSK has been actively involved in various initiatives related to global health, such as providing access to medicines in low-income countries and contributing to research and development efforts for diseases affecting underserved populations.We Are A Focused Biopharma Company With Strong Momentum And Big Ambitions, To Unite Science, Technology And Talent To Get Ahead Of Disease Together.

Vacancy Deatails

• Position : Regulatory Specialist MSR Coordination
• Department: Regulatory Affairs
• Education: M.Sc / B.Pharm / M.Pharm
• Job Lcation : Bangalore.
• Experience : 2 – 6 Years
• Salary : Rs. 28000 – Rs. 70000

Job Description

As a Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with regulatory requirements for our company’s products. You will collaborate closely with cross-functional teams to develop and execute regulatory strategies that support product development, registration, and commercialization efforts.

Responsibilities:

1. Regulatory Submissions: Prepare and submit regulatory filings, including applications for new product approvals, variations, renewals, and annual reports, ensuring accuracy and completeness.
2. Compliance Monitoring: Monitor regulatory developments and assess their impact on company operations. Maintain up-to-date knowledge of regulations, guidelines, and standards relevant to our products and markets.
3. Documentation Management: Manage regulatory documentation and records in accordance with internal procedures and regulatory requirements. Maintain regulatory databases and tracking systems to ensure timely submission and approval of regulatory documents.
4. Cross-Functional Collaboration: Work closely with internal stakeholders, including R&D, clinical development, quality assurance, manufacturing, and marketing teams, to provide regulatory guidance and support throughout the product lifecycle.
5. Regulatory Intelligence: Conduct regulatory intelligence activities to identify trends, emerging issues, and competitive landscape changes that may impact regulatory strategy or product development plans.
6. Regulatory Liaison: Serve as the primary point of contact for communications with regulatory authorities. Prepare and coordinate responses to inquiries, requests for information, and inspections from regulatory agencies.
7. Quality System Support: Assist in maintaining and improving the company’s quality management system (QMS) to ensure compliance with applicable regulations and standards, such as ISO and FDA requirements.

Qualifications:

• Bachelor’s Degree In Biological Or Healthcare Science Qualification Or Experience Within Regulatory Affairs In The Drug Development Environment.
• Minimum 2 – 6 Years Of Relevant Experience.
• Ability To Proactively Manage Workload, Timelines, And Identify Priorities.
• 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 With Knowledge Of Regulatory Agency Guidelines.
• Excellent Organizational Skills, Attention To Detail, And Commitment To Deliver High-Quality Output, Even Under Pressure.
• Excellent Written And Verbal Communication Skills.
• Ability To Interpret And Advise On Guidelines And Requirements On A Global Basis.
• Ability To Build Effective Working Relationships And Work In A Matrix Environment Effectively.
• Ability To Think Flexibly To Meet Constantly Shifting Priorities And Timelines.

How to Apply

click here to apply now – GSK Careers Applyhttps://jobs.gsk.com/en-gb/jobs/395988

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