Regulatory CMC Executive
- Istanbul, Turkey
Site Name: Turkey - Istanbul
Posted Date: Jun 1 2020
Are you looking for an opportunity to support a regulatory environment where you will be a part of cost reduction initiatives and ensure submission of packages are generated and provided to markets? If so, this is the role for you.
As Regulatory Affairs Management Professional you will be responsible for the execution of Chemistry, Manufacturing, and Controls (CMC) regulatory activities for new product regulations and life-cycle maintenance.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Develop best CMC regulatory strategies: continuous analysis of risks and opportunities
- Planning and execution of CMC submissions and conduct effective cross-functional interactions to preserve business continuity
- Follow up of developments and changes in the local & global regulations and analyzing the potential impact on the registrations
- Ensure timely regulatory submissions and approvals of technical changes
- Ensure the organization's regulatory activities are conducted accurately, ethically, and according to relevant regulations, laws, and standards
- Perform regulatory advocacy activities with internal and external stakeholders
- Review and approve regulatory CMC documents received from 3rd parties
- Convert the CMC documents into CTD modules and GSK format received directly from 3rd parties
- Provide regulatory CMC leadership to cross functional teams
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in related fields (such as Faculty of Pharmacy, Chemical Engineering, Chemistry etc.)
- Have 3-4 years experiences in regulatory field
- Have a good command of written and spoken English
- Strong command of communication and presentation skills
- Good knowledge of MS Office tools
- Strong planning, follow up, reporting and analytical skills to achieve accurate and timely results,
- Work precisely according to procedures, rules and regulations
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
You may apply for this position online by selecting the Apply now button.
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