Regulatory Affairs Associate

Develops and ensures implementation of regional RA strategy for sanofi-aventis
products.
Serves as focal point between Affiliate RA and other RA functions.
Responsibility of various countries or various registered products.
Ensures the maintenance of the A.M.M.: renewals, variations, answers to the
authorities, the coordination of the preparation of reports profit / risk.
Extension of the recordings: evaluation of files, coordination of the update
of the documentation, the definition of the strategies of recording. Job
Family Group: Regulatory Affairs - Generalist
MISSION & PURPOSE
Ensures timely product registration and licensing of Sanofi products across
the Regulatory agencies, in compliance with the applicable legislation in the
Gulf countries.
Define and implement regulatory strategies to be regulatory compliance with
Sanofi's products worldwide and support company growth. Support and advise the
assessment project tasks relevant to regulatory affairs from product inception
to product launch.
To achieve success it is critical that the Regulatory Affairs Lead:
* Responsible for the overall registration strategies
* Ensure timely submission and drive approval of all Regulatory Activities in the Gulf Region
* Ensure compliance of the product portfolio to the legal requirements of the markets
* Maintains knowledge of regulatory requirements and environment up to date
* Work closely with Internal and external stakeholders
* Support the submission preparation and approval execution for all Regulatory activities
* Support effective communication with distributors and Health Authorities in Gulf
* Review and approves promotional material in accordance with Health Authority legalization
KEY MANDATORY ACCOUNTABILITIES
* Responsible for the overall registration strategies, coordination, implementation, execution, control and completion of product registrations in Bahrain, Kuwait, Qatar, Oman and UAE which is achieved by ensuring timely submission and driving approval through compliance of all Regulatory Activities in the Guff Region.
* Maintains knowledge of regulatory requirements up to date and provides regulatory intelligence and guidance on the changes (on going and future) to local Regulatory on regulations and guidelines including assessment of their impact on Sanofi's portfolio and business.
* Work closely with Internal stakeholders on planning of regulatory activities in the Gulf Region
* Support the submission preparation in providing updated requirements and reviewing local documents.
* Support communication with our local agents and distributors in Gulf to achieve successfully submission, follow-up and approval of all regulatory activities managed by the Health Authorities in Gulf Countries.
* Coordinate locally the submission of regulatory documents and follow up on their approval, in accordance with the regulatory plan
* Maintain the regulatory tracking and planning tools in line with Sanofi's Standard Operation Procedure.
* Ensure compliance to company policies, Health Authorities and Pharma Industry Codes.
* Regulatory support for tender implementation across the Gulf Countries
* Monitor and set timelines for licence variations and renewals submissions and approvals, through ensuring maintenance of registered products in coordination with Global Regulatory Affairs, Supply, Customer Service, Commercial and Distributors to secure business continuity.
* Tracks and facilitates manufacturing site registration in line with the national requirements.
* Review and approves promotional material and activities in accordance with national legalisation and Codes of Practice and company policies and procedures.
* Ensures Regulatory labelling compliance and submission of safety updates in line with Health Authorities requirements and internal compliance deadlines
* Responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product licence.
* Builds effective relationships with Local distributors and Health Authorities based on transparency, trust and respect.
* Effective Core member of cross-functional project teams within the organization.
Maintain Compliance
* Abide by the requirements of the internal Code of Ethics including but not restricted to maintaining high professional standards of conduct in line with the Company procedure with a duty of care to the reputation of the Company
Ethical Leadership
* Takes personal accountability to use personal experience and knowledge, as well as the training and tools provided by Sanofi, to maintain a good knowledge and understanding of all ethics and governance relevant to the role (Sanofi Policies and Procedures and any relevant legal requirements) and demonstrate personal leadership in applying these to all work undertaken.
* Escalates any decisions, or seek the support of colleagues or management if personal knowledge and understanding is not at the level required to carry out any part of the role.
Environmental and Safety Leadership
* To care for his/her own safety and wellbeing and the safety of others, and to co-operate with the company to ensure a safe place of work. Employees are therefore expected to:
* Support and conform to Company safety rules and procedures to ensure a safe and healthy working environment
* Report any accident, incident or near miss, whether it be of personal injury or property damage
* Assist in the investigation of accidents with the objective of introducing measures to prevent recurrence
Thoroughly read all safety documentation issues by the Company and comply with
its requirements. Escalate any doubts or uncertainties to their supervisor and
/ or manager.
KEY WORKING RELATIONSHIPS
INTERNAL
Cross Functional Collaboration with:
* Market Access and Pricing
* Medical Affairs and Clinical Operations
* Pharmacovigilance
* Quality
* Marketing
* Supply Chain
* Business Operations
* Customer Service
* Procurement
Occasional Contact with:
* Legal
* Compliance
* Finance
* Trade and revenue team
EXTERNAL
Would be expected to be involved with:
* Sanofi Agents/Distributors in Gulf countries
* Ministries of Health across Gulf Countries
SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS
* Bachelor Degree in medical or scientific field of study (e.g. Pharmacy Chemistry or Biology)
* Minimum of ‎2-‎3 years of related experience in Regulatory Affairs in Gulf Countries
* Knowledge of applicable regulations and laws which regulates Pharmaceutical Products and manufacturers.
* Fluency in both Arabic and English
* Independent, proactive and optimistic personality with strong problem solving skills
* Action orientation and strong ability and willingness to learn new things quickly
* Excellent organization skills and ability to work on a number of projects with tight timelines is required.
* Excellent verbal and written communication and interpersonal skills
* Excellent teamwork skills
COMPETENCY REQUIREMENTS
* Stretch
* Act for patients and customers
* Take action
* Think Sanofi first
At Sanofi diversity and inclusion is foundational to how we operate and
embedded in our Core Values. We recognize to truly tap into the richness
diversity brings we must lead with inclusion and have a workplace where those
differences can thrive and be leveraged to empower the lives of our
colleagues, patients and customers. We respect and celebrate the diversity of
our people, their backgrounds and experiences and provide equal opportunity
for all.