Back

Regulatory Affairs Manager

AbbottAbbott·Healthcare

Apply effort

<60 sec

via Aplyr Quick Apply

Posted

2 days

01

About the role

JOB DESCRIPTION:

External Engagement:

  • Doing engagement to involve in the regulation discussion with government and association
  • Analysis the product until assessment the formula
  • Recommendation for next action

  • Review implication of new or revise regulation to the ANI's product
  • Provide assessment
  • Input to the RPI system
  • Giving input for new/revise regulation to BPOM as Abbott or through trade association

  • Giving input about Abbott positioning and our concern
  • Attend socialization of regulation as member of trade association
  • Doing advocacy through association for concern that may impact Abbott
  • Engagement activity to BPOM together with trade association

Operational Excellent

  • Submission and approval Product in Periodic Time
  • Together with MKT and Global to prepare document registration and packaging preparation
  • Review PMRA according regulation
  • Giving input or recommendation for communication materials

Strategic Innovation

  • Update the progress and the trend
  • Initiate and arrange meeting with KOL and BPOM
  • Submit Petition with appropriate supporting data
  • Review and assess formula
  • Give input for business decision- Helping business/sharing regulation to related part
  • Participate with other department
  • Sharing knowledge to regulator

Requirements

  • Education:  Bachelor's degree
  • Years of experience, both overall and any industry-specific experience needed:  5-8 years in FMCG and/or Food
  • Other qualifications/certifications: Familiar with Food Regulation and Local authority , has good relationship with BPOM and other regulator (MOH, BPJPH)

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

DIVISION:

AN Abbott Nutrition

LOCATION:

Indonesia > Pondok Indah : Wisma Pondok Indah 2

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

     

     

Skills & Tags

02

Aplyr's read

Abbott Laboratories is a leader in healthcare innovation, attracting professionals dedicated to advancing medical technology and patient care on a global scale.

Synthesized from recent postings & public sources

What's promising

  • Abbott's diverse product range offers stability and growth opportunities.
  • Strong global presence enhances career mobility and international experience.
  • Commitment to R&D fosters a culture of innovation and learning.

What to watch

  • Regulatory challenges can impact product launch timelines.
  • High competition in the healthcare sector pressures market share.
  • Complex organizational structure may slow decision-making processes.

Why Abbott

  • Abbott's focus on both diagnostics and nutrition sets it apart from typical pharmaceutical companies.
  • Extensive global footprint provides unique cross-border project opportunities.
  • Abbott's investment in emerging markets offers growth in diverse regions.

Aplyr’s read is generated by AI from public sources. Was it useful?

03

About Abbott

Abbott Laboratories is a global healthcare company that develops and manufactures a wide range of medical devices, diagnostics, nutrition products, and branded generic pharmaceuticals.

04

Similar roles