- Accountable for the delivery of Marketing Application, pre-approval/investigational, and lifecycle maintenance submissions to agreed timelines and in compliance with regulations and guidelines.
- Leadership of relevant submission team for product regulatory authority submission or maintenance activities.
- Scenario planning for multiple regulatory strategies and proposing delivery strategies for accelerated timelines.
- Liaising with Regulatory Agencies to resolve issues.
- Maintaining the overall RMT workplan.
- Providing guidance on GSK submission-related processes.
- Leading process improvement initiatives.
- Degree in a biological, healthcare, or scientific discipline.
- Extensive experience in the drug development environment.
- General knowledge of Regulatory Affairs responsibilities.
- Ability to interpret regulations and make consensus decisions.
- Effective interaction at different levels in a matrix environment.
- Flexible thinking to meet shifting priorities and timelines.
- Bachelor degree or higher in biological or healthcare science.
- Excellent written and verbal communication skills.
- Strong organizational skills and commitment to deliver high-quality output.
- Project management experience in the pharmaceutical industry or regulatory environment.
- Ability to lead in a matrix environment and ensure delivery of objectives.
- Proactive risk identification and mitigation, sound judgement, and stakeholder interaction.
- Leading multidisciplinary team meetings and facilitating discussions.
- Career at one of the leading global healthcare companies.
- Hybrid work (2/3 days per week in the office).
- Contract of employment.
- Attractive reward package, life insurance, and pension plan.
- Private medical package and sports cards.
- Possibilities of development within the role and company's structure.
- Personalized learning approach and extensive support for work-life balance.
- Supportive community and integration events.
- Modern office with creative rooms and daily fresh fruits.
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Submission Manager - Halifax, Canada - 9605 GSK Services Sp z o.o.
Description
Submission Manager
Works closely with the Global Regulatory Lead (GRL), Regulatory Matrix Team (RMT), global submission teams, and Local Operating Company regulatory contacts to deliver submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines as well as GSK SOPs and working practices. This role involves mentoring, coaching, training other team members, and reviewing work for right first-time submissions. The position offers the opportunity to lead key activities for career progression.
These responsibilities include some of the following:
Basic Qualifications:
We are looking for professionals with the following required skills:
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
At GSK we offer a wide range of additional benefits:
Why GSK?
Uniting science, technology, and talent to get ahead of disease together.
GSK is a global biopharma company focusing on vaccines, specialty and general medicines, immune system science, and new technologies. Join us in our journey to get ahead together, making an impact on global health and delivering sustainable returns. A place where people thrive and grow, where they can be inspired, valued, and included. Join us in this exciting moment to get ahead together.
GSK is an Equal Opportunity/Affirmative Action Employer, promoting diversity and inclusion in the workplace.
Important notice to Employment businesses/Agencies
GSK does not accept referrals from employment businesses and/or agencies without prior written authorization. Contact GSK's procurement/human resources department for authorization before referring any candidates. Unauthorized referrals are not accepted.
