Job Description
Responsible for managing MTL regulatory approval and outreach programs for GenMed, Onco and
Ophta products. Engages in trust-based scientific discussion with regulatory officials, while efficiently
gaining regulatory go-ahead for top priority MTL products and programs.
Registration and launch new product as fast as possible
Direct the preparation and presentation of all necessary regulatory documentation, through active
outreach to MTL and regional medical and CRA personnel, and management of the MTL RA team
Develop regulatory-outreach plans working closely with other CRA and Market Access personnel
to ensure efficient approval of in-country products and programs
Allocate RA personnel and resources to provide necessary documentation and support for highpriority
compounds and products
Provide necessary clinical information and documentation to MTL, regional and corporate
personnel, as necessary
Ensure clear communication channels between MTL Regulatory Affairs personnel and global and
regional Development, CRA, and Market Access officers
Support MTL Market Access initiatives/tools
Maintain and Develop a deep and strong relations with Health Authorities, Public Institutions, Public
Insurance, to improve access in MTL
Coordinate with Head of Legal for protection of Novartis licenses and Novartis Patent
Coordinate and prepare Business Cases with Marketing for launch all new product and aligned with
Global pricing strategy
Active all tasks related to the “Pharmacien Responsable” responsibilities as detailed in the article
117 of the law 17/04
Financial and Business Results
Fastest registration Product
Cost control targets for RA group
Strategy/Market Focus
Novartis reputation with regulators surveys, interviews, polls, media
Long-term MTL strategy and planning portfolio growth, coordination with Development and Market
Access roles
Regional/global coordination alignment with regional/global strategies, best-practice import/export,
Pharma forum participation
Operational Excellence
Product launch success product milestones, speed and efficiency for new products time between
approval, launch and end of P&R process,
Efficiency and success rate of regulatory submissions
Communication productivity frequency of contact with regulatory customers, time spent with tier-1
KOLs and influencers
Satisfaction of internal customers with quality and appropriateness of information/reports provided
by RA group
People, Capabilities, and Management
Strong culture RA satisfaction/commitment, “best-place-to-work” list
RA talent acquisition and development hire quality, HiPo retention and development, talent export
Code of conduct compliance
Minimum Requirements
Minimum Education University degree
Desirable Education Pharmacist/Physician
Ideal Experience 4-6 years experience in Regulatory Affairs or Medical
Clear and full understanding of relevant pharmaceutical regulation and approval processes
Ability to manage relationships with a high number of external customers
Proven ability to develop trust-based relationships with government officials, regulators
Excellent oral and written communication skills
Excellent negotiation and influencing skills
Strong presentation skills
Ability to lead and develop other scientific and professional reports
Language Requirements
Language Spoken Written Read
French/ English, Arabic
Division
Global Drug Development
Business Unit
REG AFFAIRS GDD
Country
Morocco
Work Location
Casablanca
Company/Legal Entity
NOV PHARMA MAR
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
