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Regulatory CMC Executive ?stanbul 695 GlaxoSmithKline Ilaclari Sanayi ve Ticaret A.S. ?stanbul

Regulatory CMC Executive ?stanbul

Regulatory CMC Executive ?stanbul
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

Why you?

Qualifications:

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

Why GSK?

Our values and expectations are 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

Dane kontaktowe:
Mo?esz zaaplikowa? online na to stanowisko, naciskaj?c przycisk Aplikuj.

Wa?na informacja dla biur/agencji po?rednictwa pracy

GSK nie akceptuje polece? pracowników od biur i/lub agencji po?rednictwa pracy w odniesieniu do ofert pracy zamieszczonych na tej stronie. Wszystkie biura/agencje po?rednictwa pracy s? zobowi?zane do skontaktowania si? z dzia?em handlowym i ogólnym/kadr GSK w celu uzyskania wcze?niejszej pisemnej zgody przed poleceniem kandydatów firmie GSK. Uzyskanie uprzedniej pisemnej zgody jest nadrz?dne w stosunku do jakiejkolwiek umowy (ustnej lub pisemnej) mi?dzy biurem/agencj? po?rednictwa pracy a GSK. W przypadku braku takowego pisemnego upowa?nienia wszelkie dzia?ania podejmowane przez biuro/agencj? po?rednictwa pracy b?d? uwa?ane za wykonane bez zgody lub umownego porozumienia ze strony GSK. GSK nie ponosi zatem odpowiedzialno?ci za jakiekolwiek op?aty wynikaj?ce z takich dzia?a? lub wynikaj?ce z polecenia danej osoby przez biura/agencje po?rednictwa pracy w odniesieniu do ofert pracy zamieszczonych na tej stronie
?stanbul Turkey
Regulatory CMC Executive ?stanbul 695 GlaxoSmithKline Ilaclari Sanayi ve Ticaret A.S. ?stanbul
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Das Ofenhaus Colnrade Dorfstraße 21, 27243, Colnrade DE
Das Ofenhaus Colnrade
Dorfstraße 21, 27243, Colnrade DE
odtülüler eryaman 06824 Etimesgut/Ankara TR
Odtülüler eryaman
06824 Etimesgut/Ankara TR

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