Associate Regulatory Affairs Manager Abbott Nutrition Division
Share
Job Location:
Taguig - Philippines
Monthly Salary:
Not Disclosed
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
About Abbott
Abbott is a global healthcare leader creating breakthrough science to improve peoples health. Were 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/AIn 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)
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
