Regulatory Affairs executiveGlaxoSmithKline Pte Ltd

Job Description :
e you interested in a regulatory affairs role that allows you to accelerate regulatory compliance across the business If so, this Regulatory Compliance Manager could be an ideal opportunity to explore.
As Regulatory Compliance Manager Professional, you will be responsible forcoordinating the business compliance, including transparency reporting and performing of audits to ensure that GSK is in compliance with government laws and regulations.
The position will provides leadership, strategic direction, and oversight of regulatory activities for GSKCH Philippines product portfolio. Ensures development and execution of regulatory strategies and plans and applies consistent quality standards for regulatory processes and deliverables to meet business objectives. The role is expected to partner and collaborate with key stakeholders within the organization while maintaining good external engagement.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...
Manages product registration plans to ensure maintenance of the licenses and compliance
Evaluates and prepare dossier for submission to FDA on product registration (initial and product life-cycle)
Ensures a culture of active engagement with other functional teams such as Research & Development, Quality, Medical, Marketing, Legal, Sales, Supply Chain
Ensures proactive advice to the business partners on existing and emerging regulatory trends and requirements
Coordinates internal and external audits of the company facilities and develops procedures to ensure regulatory compliance
Participates in Industry/Trade Association activities and assists in the development of strong working/partnering relationships with key agencies and stakeholders in helping influence the regulatory environment for the business
Why you
We are looking for professionals with these required skills to achieve our goals:
Bachelor's degree in Pharmacy
Familiar with a variety of the field's concepts, practices, and procedures
Relies on extensive experience and judgment to plan and accomplish goals
Strong quality and business sense
Results oriented and able to independently create and deliver
Displays initiative
Communication and presentation skills
Decision making / Problem solving
Able to gain respect of colleagues both in personal and in the area of expertise and responsibilities
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor's degree
Experience with industry reporting tools
Experience coordinating regulatory compliance efforts for pharmaceutical/biotech organization.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Advanced Degree in Science
Ability to lead by example and encourage compliance
Experience managing multiple priorities and meeting deadlines
Demonstrated experience building relationships with internal and external customers
Why GSK
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These includePatient 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.
*This is a job description to aide in the job posting, but does not include all job evaluation details.
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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GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Regulatory Affairs Executive
GlaxoSmithKline Pte Ltd
Philippines
Not Specified
Not Specified