Regulatory Affairs Manager

Thornton Tomasetti; Indonesia; On-site; IDR 180,000,000 - 240,000,000; Full time

Job summary

Abbott in Indonesia seeks a Regulatory Operations professional to manage regulatory discussions with government and associations, analyze products and assess formulas, and provide input for BPOM submissions and communications. The role collaborates with Marketing, Global teams and regulators to ensure compliance and timely registrations.

The position emphasizes building relationships with BPOM and local authorities, coordinating with KOLs and trade associations, and supporting strategic

Qualifications

• Bachelor's degree required.
• 5-8 years experience in FMCG or food industries.
• Familiar with food regulation and local authorities.
• Good relationship with BPOM and other regulators.

Responsibilities

• Engage with government and associations on regulatory discussions.
• Analyze product and assess formulas.
• Provide input to regulatory systems and BPOM submissions.
• Prepare regulatory submissions and packaging materials.
• Update progress and regulatory trends with Strategic Innovation.
• Initiate meetings with KOLs and BPOM; coordinate advocacy with trade associations.
• Submit petitions with supporting data for regulatory actions.
• Share knowledge about regulations with related departments.

Skills

Regulatory affairs

Food regulation

Stakeholder management

Regulatory submissions

KOL coordination

Education

Bachelor's degree

Job description

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)

PAY

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

WORK SHIFT

Standard

TRAVEL

Not specified

MEDICAL SURVEILLANCE

Not Applicable

SIGNIFICANT WORK ACTIVITIES

Not Applicable

COMPANY PROFILE

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life's greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. Follow Us: Facebook LinkedIn YouTube Twitter