Regulatory Affairs managerGlaxoSmithKline Pte Ltd

Job Description :
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 Manager, 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:
This position will provide support to the organization by ensuring the company's compliance to applicable regulations as mandated by the FDA and other regulatory agencies, as may be required, specifically on the company LTOs and product registrations as well as compliance to GSK's internal policies and standards.
This position will be the first point of contact between the regulatory authorities and the company.
This role also provides strategic business partnering with Commercial stakeholders and advocacy activities with the trade association and health authorities.
Develop and execute regulatory strategies to ensure the company's regulatory compliance
Maintain assigned LTO and manage regulatory inspections and audits.
Directly responsible for registration of assigned products including initial registration and life cycle maintenance, i.e., renewals and variations
Ensure labelling adherance to internal and external guidelines.  Provide strategic business partnering with Commercial stakeholders and other relevant functions.
Why you
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Graduate of Bachelor of Science in Pharmacy
Licensed Pharmacist by the Professional Regulatory Commission.
Knowledgeable in FDA policies and requirements
Minimum five (5) years experience in the regulatory function for pharma products and preferably with experience on vaccines.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Knowledge of regulatory submissions to markets
Ability to ensure compliance standards and key performance indicators are met
Regulatory expertise in knowledge of the regulatory life cycle
Ability to interact at many levels
Technical knowledge
Why GSK
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
Our goalis 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.
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Regulatory Affairs Manager
GlaxoSmithKline Pte Ltd
Philippines
Not Specified
Not Specified