Regulatory Affairs Associate (60% part time) Established Pharmaceutical Divison - Abbott - Tel Aviv

Job description

JOB DESCRIPTION:

MAIN PURPOSE:

To support the regulatory team in handling the registration of company’s products, fulfill national regulatory authority regulations and Abbott Laboratories international / local policies and procedures and local laws / regulations.

CORE RESPONSIBILITIES:

To support the company portfolio and provide regulatory guidance and support to internal groups in line with local, regional and global strategies while ensuring alignment and collaboration across Abbott.
To help maintaining product marketing authorizations including regulatory authority approvals for various regulatory activities as required.
To prepare and submit regulatory applications required in the product life cycle.
Review and provide regulatory assessment for variations.
To follow up of mandatory requirements for registration.
To interact with local, regional and global personnel on regulatory issues.
To communicate information and present status updates on product/project activities to key internal/external stakeholders.
To maintain professional knowledge and keep abreast of the legislation and highlight the potential impact on the business.
To ensure compliance with statutory obligations.

EDUCATION:

B.Pharm (A strong prefernence), B.Sc. or M.Sc.
Experience in the pharmaceutical industry/ medical device/ over the counter products/ food supplements (preferable).
Mastery of relevant regulations and the ability to stay abreast of pertinent regulations, knowledge and experience of GDP and GMP.
Fluent in English and Hebrew

APTITUDES / DISPOSITION:

Teamwork
Initiative
Innovation
Good organizational skills
Adaptability
Enthusiasm for achievement
Planning and prioritizing
High compliance and ethical standards
Strong interpersonal skills
Ability to foresee and respond to potential problems and opportunities
Project management skills

JOB FAMILY:

Regulatory Operations

DIVISION:

EPD Established Pharma

LOCATION:

Israel > Tel Aviv : Building 4

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES: