Job Description

Job Title Regulatory Affairs and Medical Associate /Dubai/

Description

We are hiring an expert Regulatory Affairs and Medical Associate /Dubai/ - with Great Benefits to join our incredible team at Aspen in Dubai.
Growing your career as a Full Time Regulatory Affairs and Medical Associate /Dubai/ - with Great Benefits is an incredible opportunity to develop excellent skills.
If you are strong in communication, critical thinking and have the right initiative for the job, then apply for the position of Regulatory Affairs and Medical Associate /Dubai/ - with Great Benefits at Aspen today!

We are looking for an energetic Regulatory Affairs and Medical Associate (Dubai) to join our passionate team at Aspen in Dubai.
Growing your career as a Full Time Regulatory Affairs and Medical Associate (Dubai) is an incredible opportunity to develop relevant skills.
If you are strong in planning, adaptability and have the right personality for the job, then apply for the position of Regulatory Affairs and Medical Associate (Dubai) at Aspen today!

Description

ROLE PURPOSE

Execution of regulatory and compliance tasks to help achieve departmental and business objectives while ensuring compliant operation within the flexibility of the regulations.

Successfully execute regulatory affairs and compliance activities for company product lines. Determine, define, and communicate regulatory requirements to individuals and project teams throughout the company.
Medical associate serves to advance science and standards of care for patients, healthcare
providers and payers, and ensure they can access all the practical and clinically relevant information and solutions
they need to use Aspen products efficiently and safely.
responsible for engaging Customers, including HCPs, in non-promotional medical and scientific discussions regarding on-market and in-development Aspen products, or on topics relating to disease states.

Temporary contact - 6-month Maternity Cover

REGULATORY RESPONSIBILITIES
Compile and submit, in a timely manner, regulatory documents according to regulatory requirements. Regular follow up on the submitted files. Ensure timely submissions as well tightly manage deficiency responses. Priority will be given to the positive margin products.
Feed the trackers provided by APTL/ group/ AGI with accurate information and provide them with input for any regulatory plan rolled out
Support market regulatory manager to develop a detailed understanding of regulatory guidelines and technical requirements in assigned countries
Work with the manager to develop and execute regulatory plans for complex projects including transfer of the newly acquired products and maintenance of licenses/authorizations for existing marketing authorizations
Work on Renewals (products and sites) submit the request as per the date mentioned in the renewal tracker. Renewal planned submission date should be met.
Provide solutions to a variety of problems of moderate scope of complexity. Interacts with internal and/or external clients. Identifies and responds appropriately to issues, providing adequate solutions.
Labelling: annotation and review of the artworks in compliance with local labelling guidelines. Artwork release when any approval is received and ensures all relevant stakeholders is informed.
Act in compliance with the internal SOP and ways of working
Ensure a proper archiving for any submitted dossier (soft copy)
Work on assigned projects to assist other affiliate where needed based on the business priority
Identify changes and modifications in the healthcare regulatory environment; and communicate those changes to appropriate individuals and departments for implementing into the organization's processes.
MEDICAL RESPONSIBILITIES
Participate in the selection process to identify appropriately qualified experts the Company would wish to engage in collaborative efforts - such as potential research collaborations, or educational and advisory roles (Advisory Boards, Congresses, Symposia, etc.); while ensuring a high level of scientific or educational integrity in these collaborative efforts.
Support internal teams such as sales and marketing and members within the regional organization to develop scientific expertise through the delivery of scientific update presentations.
Ensure a strong medical and scientific presence for Aspen portfolio in key markets by facilitation of educational initiatives, while supporting requests for medical and scientific information on products or areas of therapeutic interest to Aspen MENAT.
Deliver credible presentations on scientific matters to physicians, individually or in groups (meetings, clinical sessions, etc.), where requested by HCP- with the focus on key external experts.
Serve as a point of contact within the Medical Affairs team for external experts to satisfy their needs for scientific knowledge in a therapeutic area and, when requested, relevant AHC medicines, to support their safe, effective, and appropriate use.
Ensure that all activities and interactions are conducted with due regard to all applicable local, and national laws, regulations, guidelines, codes of conduct, Company policies and accepted standards of best practice.
Labelling: annotation and review of the artworks in compliance with local labelling guidelines. Artwork release when any approval is received and ensures all relevant stakeholders is informed.
Manage medical information mailbox and act as 24x7 main point of contact
Monitor the promotion compliance activity in the territory and responsible for review and approval of promotional material
Key Performance Indicators
Relevant Therapy Area and Product Knowledge
Translating scientific or clinical data into high quality medical information
Good understanding of drug development, statistics, and data analysis
Competent in delivering medical / scientific presentations
Managing customers and internal matrix partners
Excellent team playing and communication skills; strong sense of ownership and accountable
Requirements

EDUCATION QUALIFICATIONS AND EXPERIENCE
Bachelor's degree in Pharmaceutical Sciences /Medicine
3+ years' experience Pharmaceutical industry
TECHNICAL SKILLS
English writing & speaking - Advanced
MS Office - Advanced
Computer Skills - Advanced
KEY ATTRIBUTES
Market Knowledge
Consumer relevancy
Problem-solving
Information seeking
Flexibility and tolerance for ambiguity
Capacity for and resistance to stress
Active listening
Informal communication skills
Technical /Professional skills
Industry knowledge
Curiosity/learning agility
ASPEN COMPETENCIES

BUSINESS
Foster Consumer & Customer Commitment
Makes Good Decision
PEOPLE
Communicate Effectively
Dealing with ambiguity/Embrace change
SELF
Continuously Grow & Develop
Contribute Special Expertise
If you have not heard from the HC department within 30 days of this advert closing, please consider your application unsuccessful

Work Level

Skilled

Job Type

Contract

Salary

Market Related

Duration

( 6 Months

EE Position

No

Location

Dubai
Company Benefits:
? Excellent benefits
? Advancement opportunities
? Competitive salary
Company Benefits:
? Excellent benefits
? Company offers career progression opportunities
? Competitive salary

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