Regulatory Affairs Senior Specialist - METAP & CIS

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader that is creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow and learn, care for yourself and your family, be your true self, and live a full life. You will have access to:

• Career development with an international company where you can grow your dream career.

• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies by Fortune.

• A company recognized as one of the best big companies to work for and the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity -Regulatory AffairsSenior Specialist- METAP & CIS

This position works out of our UAE office in the Established Pharmaceutical division.

This is a fixed term contract role for 1 year.

About Established Pharmaceuticals—We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines covers multiple therapeutic areas, including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.

What You'll Do-
• Follow up on regulatory activities and plans for the assigned countries, renewal registration, registration, variation
changes, safety updates, pricing, labelling and site transfers.
• Responsible for supporting preparation and submission of dossiers according to country specific requirements and
regulations.
• Support to respond to agency questions and develops/coordinates appropriate responses.
• Support with product labelling related activities
• Provide guidance and regulatory inputs to peers and other external partners.
• Coordinate regulatory organization processes with different partners in different countries.
• Communicate efficiently with all business partners and employees
• Lead or support regulatory strategic initiatives. Act as regulatory representative on project teams and provide
advice on specific projects contributing to the development of project plans and target product profiles.
• Support, backup, solve, challenge, negotiate, act, plan and restore global and country specific regulations and
information.
• Support with health authority external engagement activities

Required Qualifications:

Bachelor’s degree of Pharmacy

Year of experience: 3-5 years experience inRegulatory Affairs within pharmaceutical segment.

Registration requirement knowledge,

Communication skills and analytical mindset

Arabic &English language

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with usat www.abbott.com,on Facebookat www.facebook.com/Abbott andon Twitter AbbottNews and AbbottGlobal.

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:

EPD Established Pharma

LOCATION:

United Arab Emirates > Dubai : Dubai Airport Freezone, Building 5WA, Floor 8

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable