Regulatory Affairs and Medical Associate - Riyadh

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.
RESPONSIBILITIES:
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.
* Work with 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.
* Provides 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

EDUCATION QUALIFICATIONS AND EXPERIENCE:
* Bachelor's degree in Pharmaceutical Sciences
* ‎3+ years experience in Regulatory affairs in the pharmaceutical field
* Nationality - Saudi
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
Internal Applicants must inform their direct line managers of their
application. Applications must be completed using an Aspen email address.
If you have not heard from the HR department within ‎30 days of this advert
closing, please consider your application unsuccessful.