Regulatory Affairs Manager

Job Summary:

Coordinate, document and complete regulatory processes, such as inspections, license renewals, or registrations. Compile and prepare materials for submission to regulatory agencies related to regulatory initiatives for Food/Nutrition*, Drug and Medical Device portfolio. Maintain regulatory compliance of products for the following regulatory lifecycle activities: initial, variations, promo permits, labelling review, among others, to ensure compliance of the company to FDA regulations for business continuity. Active participation in cross-functional team collaboration (Supply Chain, Marketing, Medical Affairs &QA) within the affiliate.  Function as the Lead NPI Representative for Abbott Nutrition RA. Provide regulatory expertise to support launch activities.  Keep updated with current local regulations and potential changes that will impact the business environment and communicated appropriately to involved or affected parties.  Single contributor role.

*98% of registration submission and lifecycle activities are in the Food Category of the Philippine FDA

Sensitive/ confidential data handled:

Product Dossiers

Product Licenses

Clinical Data

Product Labeling

Key Areas of Accountability:

1. Submissions and Approvals

a) Dossier Preparation

Prepare a quality regulatory dossier for Food/Nutritional, Drugs, Medical Device products and submit within the planned affiliate timelines. (manages majority of major brands’ initial registration, License to Operate Initial Application or variations, promo permit submission)

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

Prepare/format the dossier to ensure it meets local requirements

Review labelling materials in to comply with the necessary regulation, as applicable

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 (Reviewer in Prima or DevEx systems, provides input on regulatory information and supporting documents required for label development)

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

c) Metrics Review

Prepare monthly Regulatory Report of status monitoring and communicate to local management.

d) Regulatory Lead for NPI and Project Meetings

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

2.  Regulatory Lifecycle Compliance

a) Compliance Maintenance

Take appropriate actions to maintain all local marketed products in      compliance with local and corporate regulatory requirements Conduct compliance self-audit to identify potential compliance issues Complete Global and/or Regulatory Core Curriculum system trainings

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) and industry associations

Knowledge & Experience:

Minimum 8-year experience in performing regulatory affairs responsibilities from the Food Industry, Medical Device and/or Pharma. At least 4 years are performed in a supervisory/specialist level. Preferably with Food and Food Supplement evaluation and submission experience with the Ph FDA

Have in-depth knowledge of FDA-Center for Food Regulation and Research regulations pertaining to product registration and related submission activities (eg but not limited to promo applications, import permits)

Professional Competencies required:

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

Good knowledge of written and spoken English

Strong and competent project management and organization skills

Ability to handle and multi-task activities

Analytical skills: accuracy, reliability, attention to detail

Minimum Qualification:

Graduate of: Bachelor's degree (or equivalent) is required - preferred area of focus in science (Nutrition, Food Technology, Pharmacy, Industrial Pharmacy)