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CTA/IND Submission lead-Submission Delivery Excellence
4-7 years
Bangalore / Bengaluru
1 vacancy
CTA/IND Submission lead-Submission Delivery Excellence
GlaxoSmithKline Pharmaceuticals
posted 15hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
CTA/IND Submission lead-Submission Delivery Excellence-Investigational , position holder(s) will be accountable for Regulatory Submission Delivery professionals in end-to-end processes to meet GSKs Investigational Drug
Developments and Regulatory compliance obligations.
The position holder will act as an SME between GRO and GCO on operational topics related to Investigational Drug Development processes.
This position involves influencing stakeholders within and beyond GRA and driving harmonization and business change activities within the function, in addition to ensuring on time and quality delivery of submissions for R&D
development projects.
This role provides Regulatory management to link the business mission, strategy, and required processes to fulfil GSK s obligations with Health Authorities related to Regulatory submissions and will contribute to driving continuous
improvement and innovation of GSK Regulatory systems and processes.
The submission lead will work collaboratively with stakeholders to agree on priorities and implementation timelines for Regulatory submissions globally to maximize the business value from a GSK perspective while meeting
Regulatory Authority requirements.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following
- Submission lead will be responsible for the following, along with other value-added tasks as agreed withcustomers and leadership:
- Leveraging detailed submission requirement knowledge and technical capabilities to deliver fit forpurpose and quality submission packages per agreed schedules.
- Preparation of CTA packages (EU & Non-EU) including authoring of the EU Application forms and Market Specific documents, and compilation with other submission components (IB, protocol, IMPDetc)
- Preparation and delivery of submission packages for CTA amendments, EU End of Trial Notifications (EOTN) and EU Study Summary submissions.
- Plan and project manage the authoring and compilation of New US INDs with clinical, Regulatoryand R&D Project team members.
- Precisely and consistently following Regulatory System processes which are aligned to GRA SOPs, Work Instructions, and How to Guides.
- Maintains a Patient Focused mindset while driving the implementation of more efficient e2e processes,eliminating unnecessary handoffs and siloed responsibilities.
- Advocating and driving the use of Regulatory Systems with stakeholders and submission deliverableproviders.
- Ensuring team members adherence to agreed SLAs and assessing individual and team performance.
- Participates in defining WoWs in conjunction with Stakeholders with a focus on continuous improvement,identification and implementation of automation opportunities, and compliance with Regulatory authorityrequirements.
- Partners with peer colleagues in Submission Delivery Excellence and the Regulatory Asset Oversight teamto maximize resources and to identify and remove barriers that will prevent a successful outcome onsubmission delivery targets.
- Responsible for ensuring proper training for staff and resourcing of deliverables.
- Serves as SME on Written Standards updates and continuous improvement initiatives, when required.
- Maintains awareness of emerging Investigational regulatory requirements across regions in scope of role
Why you?
Qualifications :
We are looking for professionals with these required skills to achieve our goals:
- D egree in a biological, healthcare or scientific discipline or extensive experience within the drug development environment
- Experience in Pharmaceutical Regulatory Affairs with global regulatory procedures and submission requirements.
- Knowledge of global regulations and standards for regulatory applications.
- Ability to lead submission delivery activities within a Regulatory Operational team.
- Capable of working independently or leading a team to ensure timely project delivery.
- Project Management skills managing multiple activities across various sites.
- Ability to add value in matrix teams within a global organization.
- Ability to implement new processes and quality initiatives with relevant controls.
- Guide and advise Regulatory project teams on Regulatory Investigational submissions.
- Familiarity with Regulatory Submission Management and connections between regulatory systems.
- Assess and interpret Regulatory Requirements with Business Process Owners to develop solutions.
- Ability to work with minimal supervision.
Why GSK?
At GSK we offer a wide range of additional benefits:
- Career at one of the leading global healthcare companies
- Hybrid work ( 2/3 days per week from the office)
- Contract of employment
- Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
- Life insurance and pension plan
- Private medical package with additional preventive healthcare services for employees and their eligible counterparts.
- Sports cards (Multisport)
- Possibilities of development within the role and company s structure
- Personalized learning approach (internal trainings, mentoring, access to online training platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
- Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities).
- Supportive community and integration events
- Modern office with creative rooms, fresh fruits every day
Employment Type: Full Time, Permanent
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What people at GlaxoSmithKline Pharmaceuticals are saying
Lead salary at GlaxoSmithKline Pharmaceuticals
reported by
3
employees
with 4-9
years exp.
₹12.5
L/yr - ₹31
L/yr
58%
more
than the average Lead Salary in India
View more details
What GlaxoSmithKline Pharmaceuticals employees are saying about work life
based on 1.8k employees
Flexible timing
Monday to Saturday
Within city
Day Shift
GlaxoSmithKline Pharmaceuticals Benefits
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CTA/IND Submission lead-Submission Delivery Excellence
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Bangalore / Bengaluru
CTA/IND Project manager-Submission Delivery Excellence
6-9 Yrs
Bangalore / Bengaluru
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