Sr. Regulatory Affairs Specialist - Abbott Nutrition Division

     

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Nutrition

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure® and Glucerna® – to help get the nutrients they need to live their healthiest life.

The Opportunity
Key Areas of Accountability:

1. Submissions and Approvals

a) Dossier Preparation

Prepare a quality regulatory dossier for Food/Nutritional (major brands), Drugs, Medical Device products and submit within the planned affiliate timelines.

• Request and obtain the various  regulatory items needed for the local submission

• Reviews Clinical Documentation to support product label claims

• Prepare/format  the dossier to ensure it meets local requirements

•  Implement the submission and archive appropriately

b) Gain Regulatory Approval

Gain Food and Drug Administration (FDA) or respective regulatory agency approvals to meet the affiliate product launch plans and ensure product maintenance.

• Provide quality responses to the FDA on or before the due date

• Complete regulatory approval process and gain product licenses.

• Communicate Product approval

• Archive submission dossier and approval documents

• Perform regulatory responsibilities related to label and packaging development

• Ensure the local label creation and packaging development will meet local and corporate criteria and support the business needs

c) Metrics Review

Prepare periodic Regulatory Report of actual submissions and approval and communicate to local management

d) Regulatory Lead for NPI Project Meetings for assigned products

Ensure knowledge and understanding of the on-going regulatory projects and manage with cross-functional team.

2.  Regulatory Compliance

a) Compliance Maintenance

Take appropriate actions to maintain all local marketed products in compliance with local and corporate regulatory requirements

• All aspects of labeling and label change management;

• chemistry and manufacturing commitments that are registered with the Food and Drug Administration

Conduct compliance self-audit to identify potential compliance issues Review promotional materials per policies Complete Global and/or Regulatory Core Curriculum and Good Regulatory Practices training

3. Regulatory Influence

        a) Regulatory Customer Relations

Keep abreast of regulatory updates, changes and trends affecting local

regulations which could impact business environment and communicate appropriately with affected parties.

b) External Engagement

To maintain and strengthen communication with appropriate offices of the Food and Drug Association (FDA), National Dairy Authority (NDA) and industry associations

Job Specification

Knowledge & Experience:

• Minimum 5-year experience in performing regulatory affairs responsibilities from the Food Industry/ Pharma and/or Medical Device, of which at least 2 years are performed in a supervisory/specialist level

• Experience in FDA Center for Food regulations, preferred

• Have in depth knowledge of local regulations pertaining to product registration requirements in the Center for Food

Professional Competencies required:

• Knowledgeable in operation of Microsoft Word, Excel, Powerpoint and Adobe Acrobat Professional;

• Good knowledge of written and spoken English

• Competent project management skills

• Ability to handle multi-task activities

• Analytical skills: accuracy, reliability, attention to detail

Graduate of:

B.S. Food Technology or Nutrition/ Community Nutrition or allied courses

B.S. Pharmacy

B.S. Industrial Pharmacy

     

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:

Philippines > Taguig City : Venice Corporate Center

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)