Regulatory Affairs Protégé Program null

Your role

Role description & responsibilities:

• The Regulatory Affairs Protege for GRS IRSP-Asia is responsible for assisting GRS-RSPI Asia in the preparation and submission of registration documents to the Regulatory Authority and other administrative tasks.
• Administrative Duties:
  • Handle ad-hoc administrative tasks Records and documentation maintenance (filing, photo stating, store maintenance, dispatch arrangements, archiving, maintaining teams repositories, etc.) Submit e-payment request
• Regulatory Duties (if applicable)
  • Product Registration: Prepare the template for the compilation of the registration dossier. Assist in the preparation of post-approval changes (major and minor variations). Permits and tender applications Assist in handling permit applications Assist in handling name patient basis applications Assist in handling import license application Provide documentation support for tender application Post Market surveillance coordination assistance System and database maintenance Assist in compiling and organizing regulatory final guidelines, drafts, policies, etc. Assist in supporting project/ process improvement.
• Self Development
  • Attend relevant technical and self-development training.
• Other duties that may be assigned by GRS-IRSP Asia

About you

Technical skill requirements:

• Key competencies expected for the job:
  • Training required include training as stated in the Training Program for the Job
• Training program for the job:
  • Relevant and required Regulatory Systems Training
  • Relevant and required SOPs as assigned in PLA and Pfizer Malaysia Policies and Procedures SharePoint.
• Relevant Malaysia & Brunei MOH Drug Registration Guidelines and regulatory Processes system
• Other relevant pieces of training
• Academic:
  • Bachelor's degree in Science
• Experience:
  • Affiliation and active participation in college co-curriculum activities.
  • Should be resourceful and diligent.
  • Possess good interpersonal skills.
  • Good communication skills both written and verbal.
  •  Computer literate (must be knowledgeable in using MS Applications: MS Word, MS Excel, MS PowerPoint), and also knowledgeable in using the internet and online sources

Benefits

Pfizer offers competitive compensation and benefits based on a variety of factors including prior experience, geographic location, and talent pool availability. Depending on the customs and laws of a specific country, Pfizer offers colleagues health and wellness programs, benefits to help colleagues meet financial goals and access to colleague-directed retirement funds.

 

 

 

 

Lihat postingan ini di Instagram

 

 

 

 

 

 

 

 

 

 

 

Sebuah kiriman dibagikan oleh Pfizer Careers (@pfizercareers)

Training & development

In general, Pfizer works hard to ensure that people are supported to do their best work. Collaboration underpins everything Pfizer does here. That’s why Pfizer's leaders and managers take an active role in developing colleagues and helping them fulfill their career goals – whatever they may be. That support includes:

• Individual Development Plans: Pfizer's leaders work with you to take into account colleague interests and aspirations as well as Pfizer’s business needs.
• Pfizer actively promotes mentoring
• Internal Advancement: Colleagues may freely explore and apply for positions within Pfizer as all positions are posted on the Pfizer job page
• Short- and Medium-Term Experiential Opportunities: Through activities like secondments, Pfizer offers colleagues a variety of short- and medium-term career development opportunities.
• Learning & Development Opportunities: Colleagues can take advantage of learning and development opportunities, and training programs, focused on hundreds of topics, including job-specific learning, and general business, manufacturing, finance, and technology skills.

Career progression

In this role, you will have career exposure in External Communications and Corporate Affairs. While it does not specify the career path offered to participants after completing this program, in general, Pfizer offers Internal Advancement where you may freely explore and apply for positions within Pfizer as all positions are posted on the Pfizer job page.

Sources

Information on this page was gathered based on the sources below:

• pfizer.com/about/careers/en-ir/career-development
• pfizer.com/sites/default/files/investors/financial_reports/annual_reports/2019/our-purpose/our-values-and-culture/index.html
• glassdoor.com/Reviews/Pfizer-Malaysia-Reviews-EI_IE525.0,6_IL.7,15_IN170.htm?filter.iso3Language=eng