• Regulatory Affairs Specialist Jobs in Indonesia - 25364635

  • Procter & Gamble (P&G)
  • Indonesia
  • Save Job
  • 1 - 3 Years
  • Posted : above 1 month

Job Description:

Regulatory Affairs Specialist

Description
Overview of the job

In this role you will perform regulatory activities for healthcare products including medicines (RX/OTC) and will work with projects of new submissions and maintenance for Indonesia

Your team

This role reports to Head of Regulatory Affairs (RA) Working in the RA team of P&G, all of our roles provide competitive wages as well as the opportunity to engage and grow in your profession across growing categories In this team, you will help deliver our brands advances to market and will support procedures to ensure the compliance of all products and retail packages Moreover, the team will maintain marketing authorizations (MAs) for various P&G health products of brands Vicks, Neurobion, Sangobion, Sevenseas, Iliadin, etc

What success looks like

Able to negotiate and take the lead in driving regulatory bodies on product registrations

Collaborate with business partners in business process changes and, where needed, driving them to meet the updated regulation

Able to clearly present information, influence, or persuade others through oral presentation in positive or negative circumstances

Able to take action in solving problems while exhibiting judgement and a realistic understanding of issues In addition, able to use reason even when dealing with emotional topics

Responsibilities of the role

Support the Head of RA in generating local registration strategies, planning for New Product Development (NPD) to support local business objectives, and planning to ensure compliance with both company and relevant local regulations (ie variations, renewals)

Actively participate in cross functional meetings or coordinations for NPD and maintenance activities

Ensure a qualified registration dossier is prepared and meeting with the most current requirements in timely manner

Submit, negotiate, and take a lead in driving regulatory bodies on registration and renewal of new products and variations

Take any necessary actions in order to accelerate the approval

Keep in close contact with Life Cycle Management (LCM), production, Quality Control (QC), and Quality Assurance (QA) with regards to development dossiers and documentation

Lobby, build, and maintain close relationship with registration authorities and other relevant pharmaceutical organizations

Support marketing team (ie review and provide feedback/challenge) in the development of new pack materials and advertisement materials

Manage the approval process of new pack materials and Point of Sales Materials (POSM) with Badan Pengawas Obat & Makanan (BPOM)(National Agency of Drug and Food Control of Republic of Indonesia)

Constantly work on achieving BPOM acceptance of marketing campaigns and designs

Have well trained on relevant regulatory system and database, and ensure these are maintained up to date

Qualifications
Bachelors Degree or above, Pharmaceutical major

Knowledgeable and has 1-3 years experiences in product registration (OTC and Health Supplement products preferred) and dealing with related government agencies (ie BPOM, Kemenkes)

Proven ability of critical thinking and problem solving

Strong verbal and written communication skills, fluency in English

About us

We produce globally recognized brands and we grow the best business leaders in the industry With a portfolio of trusted brands as diverse as ours, it is paramount our leaders are able to lead with courage the vast array of brands, categories and functions We serve consumers around the world with one of the strongest portfolios of trusted, quality, leadership brands, including Always, Ariel, Gillette, Head & Shoulders, Herbal Essences, Oral-B, Pampers, Pantene, Tampax and more Our community includes operations in approximately 70 countries worldwide

Visit http//wwwpgcom to know more

Our consumers are diverse and our talents - internally - mirror this diversity to best serve it That is why were committed to building a winning culture based on Inclusion and our ideal candidate is passionate about the same principle you will join our daily effort of being in touch so we craft brands and products to improve the lives of the worlds consumers now and in the future We want you to inspire us with your unrivaled ideas

We are committed to providing equal opportunities in employment We do not discriminate against individuals on the basis of race, color, gender, age, national origin, religion, sexual orientation, gender identity or expression, marital status, citizenship, disability, veteran status, HIV/AIDS status, or any other legally protected factor

Job locations
Jakarta, Jawa, Indonesia Job Type Full-time Req No RND00004361

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Consumer Durables/FMCG, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 09th Jun 2020

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