Job Description

Regulatory Manager

What You'll 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 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.
• 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 variation’s 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-

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 at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

The base pay for this position is

N/A

In 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