GSK is recruiting CDD
Regulatory Affairs Specialist
- Site Name: Field Worker – CHN
- Posted Date: Mar 18 2022
- Job Purpose
Contribute To The Business Objectives And Goals
- By ensuring regulatory compliance is achieved and maintained
- By making the product available for patients.
- Maintain compliance to company policies and local regulatory requirements.
Your Key Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Key Deliverables
Implement portfolio optimization plan in line with EM strategy and local requirements:
-
- by registering new products.
- by registering line extensions.
- by cancellation of dormant/non-marketed licenses
- Support commercial on delivering new business opportunities (tenders, partnership, …)
Maintain Regulatory Compliance, Therefore Ensuring Product Supply Continuity
- by registering variations (clinical/technical) in a timely manner.
- by renewing product licenses in a timely manner.
- Implement and maintain effective Quality Management System
Key Responsibilities
- Implement registration plan in line with group strategy and local business opportunities.
- Develop and implement regulatory strategies for significant value driving opportunities (line extensions, new indications).
Maintain regulatory compliance with life cycle maintenance of the licenses:
- Support timely submission of key labelling changes with commercial priority to foster total alignment across commercial and regulatory teams.
- Ensure compliance is maintained for our local Prescribing Information in alignment with reference markets Prescribing information
- Manage evaluation of the dossier content and submission of CMC variations on time to ensure supply continuity.
- Provide assessment for upcoming variations and advise the strategy of the submission / bundling in agreement with commercial team
- Ensure all license renewals dossiers are submitted in timely manner according to the annual established plan.
- Close collaboration with central team to get a right first-time dossier ready for submission.
- Lead contact and negotiation with local Health Authorities and internal stakeholders to build and cultivate trusted partnerships.
Ensure The Effective Implementation Of Artwork Management Procedures
- by creating initial artworks/packs at product launch
- by maintaining artworks/packs in line with registered details
- Review artwork changes for shared artwork components
- Initiate a change request for market specific pack
- Maintain Regulatory systems compliant in line with global SOPs.
- Maintain our KPI compliant in line with global SOPs.
- Archive and maintain on a regular basis Dossiers and Regulatory records.
- Run the management monitoring for key & critical process as per the agreed plan based on management monitoring universe.
- Submit promotional materials to health authorities
- Follow with customer service the importation & release of regulatory/registration samples.
Why you?
Basic Qualifications
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree in science related field.
- 5 -7 years of experience in pharmaceutical industry within regulatory affairs.
- Knowledge of country & EU regulations / ICH /GDP standards.
- Technical and pharmaceutical knowledge.
- Cross-functional working skills.
- Fluency in English.
- Good organization skills.
- Communication skills.
- Analytical mindset and good problem-solving skills.
- High level of ethics & integrity
Preferred Qualifications
- Pharmaceutical background.
- Experience in Regulatory Affairs.
- Preferred experience in quality assurance systems particularly in the areas of product incidents, artwork control and audits
Why GSK?
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we’re making the biggest changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
Contact Information
You may apply for this position online by selecting the Apply now button.
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