Regulatory Affairs Associate

Job description

JOB DESCRIPTION:

Coordinate and document regulatory processes, such as inspections, license renewals, or registrations. Compile and prepare materials for submission to regulatory agencies related to regulatory initiatives. Maintain regulatory compliance of products for the following regulatory activities: initial, renewal, variations, promo permits, marketing materials, labelling review, among others, to ensure compliance of the company to FDA regulations for business continuity. Active participation in cross-functional teams (Supply Chain, Marketing, Medical Affairs &QA) within the affiliate and provide regulatory expertise and insight.  Keep updated with current local regulations and potential changes that will impact the business environment and communicated appropriately to involved or affected parties.

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.

• 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 (e.g. PRIMA Label Development Coordinator or Job Packet Manager, as required)
• Ensure the local label creation and packaging development will meet local and corporate criteria and supports the business needs

c) Metrics Review

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

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 (Product Information and packaging development e.g PRIMA Label Development Coordinator or Job Packet Manager, as required) label change management;
• chemistry and manufacturing commitments that are registered with the DRA

Conduct compliance self-audit to identify potential compliance issues

Review promotional materials as per the Promotional Guidelines and the Corporate Promotional Policies, where regulatory input is required

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.

Job Specification

Knowledge & Experience:

• Minimum 1 year experience in performing regulatory affairs responsibilities in Pharma and/or Medical Device and/or Food Industry;
• Have in depth knowledge of local regulations pertaining to product registration requirements

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

Minimum Qualification:

Graduate of:

- B.S. Pharmacy, a Licensed Pharmacist, preferred

- B.S. Industrial Pharmacy, a Licensed Pharmacist preferred

- B.S. Food Technology

Minimum 1 year experience in performing regulatory affairs responsibilities in Pharma and/or Medical Device and/or Food Industry

JOB FAMILY:

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