Regulatory Manager
موقع الوظيفة:
الراتب شهرياً:
تاريخ النشر:
عدد الوظائف الشاغرة:
ملخص الوظيفة
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. Youll 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 worlds fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology womens health cardiometabolic pain management/central nervous system and respiratory.
What Youll do-
Follow up on regulatory activities and plans for the assigned countries renewal registration registration variation changes safety issues pricing labelling and site transfers.
Responsible for preparation of submission dossiers according to country specific requirements and regulations
Responsibilities will include different country requirements and tasks falling under the umbrella of regulatory for pharmaceutical products coordinate and align all countrys 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 countrys needs.
o Develop and create new labelling printout according to countrys 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.
Interaction with health authorities throughout the lifecycle of products
Ensure that registration files are put together and include all necessary documents for quicker submission and approval.
Provide guidance to peers and other external partners.
Coordinate Regulatory organization processes with different partners in different countries.
Communicate efficiently with all business partners and employees.
Handle Health Authority queries
Active member of different RA network for different countries for challenging and getting into one industry regulatory voice of customer.
Act as regulatory representative on project teams and provide advice on specific projectscontributing 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.
Communication and best practice service for internal and external partners.
Re-challenge the HA and regulatory responsible on the variations tools and laws
Find out the best way of providing information and best communication between all departments and functions.
Strategic Planning:
Evaluate regulatory risks of corporate policies.
Provide strategic guidance for product development and planning throughout the product lifecycle.
Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
Develop global regulatory strategies and update based upon regulatory changes.
Utilize technical regulatory skills to propose strategies on complex issues.
Monitor trade association position for impact on company products.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
Participate in applicable trade association/industry working groups to influence policy/rulemaking in alignment with business strategies.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Compliance
Identify emerging regulatory issues and analyses broad scope implications of changing regulations and guidance.
Accountable for compliance with Regulatory SOPs and identification of improvement opportunities for SOPs.
Training & Translation:
Qualified as trainer for training on local procedure.
Authorized to perform Arabic to English and English to Arabic translation.
Required Qualifications-
Bachelors 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 on LinkedIn athttps:// and on Facebook athttps://
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
Required Experience:
Manager
عن الشركة
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... اعرض المزيد
