Regulatory Manager

Abbott Vascular

Gulf, Dubai

8-10 Years

Save

Posted an hour ago
Be among the first 10 applicants

Early Applicant

Job Description

Regulatory Manager

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'll also have access to:

Career development with an international company where you can grow the career you dream of.
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our UAE location in the Established Pharmaceutical Division

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 reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.

What You'll do-

u2022 Follow up on regulatory activities and plans for the assigned countries, renewal registration, registration, variation changes, safety issues, pricing, labelling and site transfers.
u2022 Responsible for preparation of submission dossiers according to country specific requirements and regulations
u2022 Responsibilities will include different country requirements and tasks falling under the umbrella of regulatory for pharmaceutical products, coordinate and align all country's specific regulatory and registration requirements.
o Provide regulatory support for tender business.
o Respond to agency questions and develops/coordinates appropriate responses.
o Initiate the pricing documents based on each country's needs.
o Develop and create new labelling printout according to country's regulations for our core products without any disruption of the existence of these products.
o Communicate the updated patient Information Leaflet.
o Review promotional materials and submit to the agency in countries Where MOH approvals are required.
u2022 Interaction with health authorities throughout the lifecycle of products
u2022 Ensure that registration files are put together and include all necessary documents for quicker submission and approval.
u2022 Provide guidance to peers and other external partners.
u2022 Coordinate Regulatory organization processes with different partners in different countries.
u2022 Communicate efficiently with all business partners and employees.
u2022 Handle Health Authority queries
u2022 Active member of different RA network for different countries for challenging and getting into one industry regulatory voice of customer.
u2022 Act as regulatory representative on project teams and provide advice on specific projectscontributing to the development of project plans and target product profiles.
u2022 Support, backup, solve, challenge, negotiate, act, plan and restore global and country specific regulations and information.
u2022 Communication and best practice service for internal and external partners.
u2022 Re-challenge the HA and regulatory responsible on the variation's tools and laws
u2022 Find out the best way of providing information and best communication between all departments and functions.

Strategic Planning:
u2022 Evaluate regulatory risks of corporate policies.
u2022 Provide strategic guidance for product development and planning throughout the product lifecycle.
u2022 Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
u2022 Develop global regulatory strategies and update based upon regulatory changes.
u2022 Utilize technical regulatory skills to propose strategies on complex issues.
u2022 Monitor trade association position for impact on company products.
u2022 Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
u2022 Participate in applicable trade association/industry working groups to influence policy/rulemaking in alignment with business strategies.
u2022 Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Compliance
u2022 Identify emerging regulatory issues and analyses broad scope implications of changing regulations and guidance.
u2022 Accountable for compliance with Regulatory SOPs and identification of improvement opportunities for SOPs.

Training & Translation:

u2022 Qualified as trainer for training on local procedure.
u2022 Authorized to perform Arabic to English and English to Arabic translation.

Required Qualifications-

Bachelor's degree with 8-10 years of relevant experience in a similar role withing pharmaceutical industry based in UAE

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 us atabbott.com, on LinkedIn athttps://www.linkedin.com/company/abbott-/, and on Facebook athttps://www.facebook.com/AbbottCareers.