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22/04 Kimberlee
HR Manager at GSK

Views:41 Applications:10 Rec. Actions:Recruiter Actions:0

GSK - Senior Regulatory Specialist - CMC Renewals (5-10 yrs) Premium

Bangalore Job Code: 917175

Job description:


Site Name: Bengaluru Luxor North Tower


Job Purpose:


- Responsible for the GRPD regulatory delivery activities (e.g., Variations <CMC & Therapeutic>, Product Expansion dossiers, Renewals, MSRs <CMC&non-CMC>) of assigned projects with minimal input from line manager.

Supports Global Regulatory by producing appropriate components for global regulatory dossiers with minimal input from line manager.


- Has training responsibilities for new staff on established departmental processes.


Key Responsibilities :


- With minimal input from manager, executes agreed dossier strategy.


- With minimal input from manager, manages multiple project assignments (e.g., Variations <CMC & Therapeutic>, 

Product Expansion dossiers, Renewals, MSRs <CMC&non-CMC>) simultaneously; dossiers will range in complexity.


- With minimal input from manager, completes data assessment to ensure dossier is fit for purpose.


- With minimal input from manager, identifies risks associated with submission data and information packages.


- Communicates with line manager to identify issues that have business impact.


- May have dossier review responsibilities for 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 products, to expedite submission, review and approval of global regulatory applications.


- Understands internal/external Regulatory environment.


- Actively builds an organizational network.


- Communicates across GSK, with minimal input from manager regarding project and policy issues ensuring optimum position for GSK.


Minimum Experience:


- Minimum 5 years of experience.


Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK.

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Women-friendly workplace:

Maternity and Paternity Benefits

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