Title: Regulatory & Quality Assurance Manager

Reports to: General Manager

PRIMARY OBJECTIVE:
The purpose of affiliate regulatory & quality assurance (QA) involves ensuring all Abbott Nutrition products are developed and maintained within the appropriate country regulatory requirements with SE Asia and Global insight. The scope of products includes pediatric nutrition, medical nutrition, and nutrition devices.

PRIMARY FUNCTIONS:

The primary functions of this position include the following related activities:

1. Manage regulatory & QA projects and provide regulatory and technical oversight to ensure timely submission and approval of dossiers and product compliance.

2. Manage and provide oversight for regulatory relationships with Agency counterparts or Area groups within the scope of responsibility.

3. Provide regulatory, compliance advice, consultation and support to Abbott’s business units.

4. Manage change in compliance with applicable global regulations & QA.

5. Identify regulatory risks/opportunities for projects in area of responsibility and propose strategies to address risks.

The individual is expected to work independently and from a strategic perspective in these functions, considering broad business impact of regulatory & QA decisions.

6. Effectively influence other functional areas to execute projects within area of responsibility. The individual is expected to work independently in this function.

CORE JOB RESPONSIBILITIES:

Specific major duties and responsibilities of this position include the following:

1. Provide regulatory and QA support (product and process expertise) for development projects and marketed products. This includes a range of activities, from participation in project meetings to formulate submission strategies, managing changes requiring regulatory notification/submission, and setting/maintaining the required regulatory submission and quality standards. This may consist the following tasks:

a. Review of technical reports.
b. Assessment of regulatory requirements to execute a Singapore and/or SE Asia submission or technical reference.
c. Managing the preparation and submission of regulatory documents to Agencies.
d. Tracking the progress of regulatory submissions with Agencies and communicating progress to the appropriate project teams.
e. Addressing inquiries from regulatory Agencies and providing responses within the agreed upon timelines.
f. Providing feedback on quality issues that have a regulatory impact.

2. Be an active member of project (development or marketed product) teams.

3. Provide regulatory and QA expertise related to nutrition issues that impact development and marketed products. This may involve assessing scientific data for submissions and providing strategies for efficient presentation of data.

4. Actively communicate with local authorities and through the area regulatory group with all other regulatory agencies related to the submission and approval of regulatory applications (e.g., managing the preparation and filing of answers to deficiency letters from regulatory agencies).

5. Actively promote communication within Nutrition Regulatory Affairs, QA and government agencies.

6. Maintain an awareness of industry and global regulatory requirements that impact Abbott related to the development and maintenance of products.

EDUCATION/QUALIFICATIONS/EXPERIENCE:
• BS, MS, or PhD in Nutrition, Chemistry, Pharmaceutical, Engineering or related field.
• Knowledge of global regulations impacting foods/nutrition/devices.
• Knowledge and experience of working in a GMP environment and the impact of regulatory decisions on the business.
• Excellent communication/negotiation (oral and written) and interpersonal skills. Ability to articulate a clear regulatory position while maintaining a positive team dynamic.
Minimum six years of experience in a regulatory technical position within R&D, Manufacturing Sciences, Quality Assurance and/or Regulatory Affairs.