JOB PURPOSE
:
As part of the GRA Marketed portfolio Strategic Management team “MPSM (COE) Associate” for Egypt and Sudan will report to MPSM ME Arabic Speaking Countries Cluster Head.
To achieve success it is critical that the MPSM (COE) Associate :
- Will be responsible for the management of the life cycle management activities and regulatory compliance of a portfolio of Rx marketed products including Biologicals, Vaccines,Chemical in one or several countries.
- He/she will be responsible for the post-approval changes including dossier evaluation, dossier preparation and dispatch to the Affiliate RA teams for submission in line with local regulations and planning set up by Global/Regional BU/Country regulatory teams.
- Dispatches ready to submit high quality dossiers within defined KPIs/timelines to ensure HA approvals are received wo any deficiency letter
To achieve success it is critical that the MPSM (COE) Associate :
- Will be responsible for the management of the life cycle management activities and regulatory compliance of a portfolio of Rx marketed products including Biologicals, Vaccines,Chemical in one or several countries.
- He/she will be responsible for the post-approval changes including dossier evaluation, dossier preparation and dispatch to the Affiliate RA teams for submission in line with local regulations and planning set up by Global/Regional BU/Country regulatory teams.
- Dispatches ready to submit high quality dossiers within defined KPIs/timelines to ensure HA approvals are received wo any deficiency letter
KEY RESPONSIBILITIES AND DUTIES:
1. Manage and monitor the regulatory compliance of the marketed product portfolio
- Manage and monitor the regulatory compliance of the marketed product portfolio under responsibility
- According to the country regulatory requirements and plannings, prioritization ,assesment, coordination, and preparation of ready- to- submit regulatory dossier:
- Labeling, CMC, administrative variations
- Renewal /annual report
- Packaging and artworking
- Site registration
- Tender
- and /or any type of response documents to the Health Authorities questions by interacting with the relevant stakeholders (BU region regulatory, GRA, RSO local medical, local Pharmacovigilance department etc.) and monitoring of dossiers dispatch up to submission.
- Ensure regulatory compliance with products overall strategies and Health authorities country requirements evaluation
- Ensure tender preparation if regulatory dossiers are needed
- Be compliant with all internal and external requirements, procedures and tools,
- Foster an environment/culture of learning and sharing of best practice within the team
2. Develop and maintain a good working relationship with internal and external stakeholders
- be a business partner for the BU/Country regulatory team
3. Ensure the overall implementation of goals and strategies of the group
- ensure the harmonization of ways of working with Affiliate RA and RSO teams as MPSM team member .
- implement in timely manner Regional BU/country planning, dispatch and ensure alignment between COE activities and Regional BU/Country activities via “mutually agreed roles and responsibility sharing docs”
4. Manage some projects /Lead specific roles
- Lead some specific roles especially about the establishment of objectives and development of team goals, coordination of some activities
5. 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
6. 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
7. Environmental and Safety Leadership
- To care for his/her own safety and well being 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.
- Manage and monitor the regulatory compliance of the marketed product portfolio under responsibility
- According to the country regulatory requirements and plannings, prioritization ,assesment, coordination, and preparation of ready- to- submit regulatory dossier:
- Labeling, CMC, administrative variations
- Renewal /annual report
- Packaging and artworking
- Site registration
- Tender
- and /or any type of response documents to the Health Authorities questions by interacting with the relevant stakeholders (BU region regulatory, GRA, RSO local medical, local Pharmacovigilance department etc.) and monitoring of dossiers dispatch up to submission.
- Ensure regulatory compliance with products overall strategies and Health authorities country requirements evaluation
- Ensure tender preparation if regulatory dossiers are needed
- Be compliant with all internal and external requirements, procedures and tools,
- Foster an environment/culture of learning and sharing of best practice within the team
2. Develop and maintain a good working relationship with internal and external stakeholders
- be a business partner for the BU/Country regulatory team
3. Ensure the overall implementation of goals and strategies of the group
- ensure the harmonization of ways of working with Affiliate RA and RSO teams as MPSM team member .
- implement in timely manner Regional BU/country planning, dispatch and ensure alignment between COE activities and Regional BU/Country activities via “mutually agreed roles and responsibility sharing docs”
4. Manage some projects /Lead specific roles
- Lead some specific roles especially about the establishment of objectives and development of team goals, coordination of some activities
5. 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
6. 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
7. Environmental and Safety Leadership
- To care for his/her own safety and well being 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:
- AMEE COE Cluster Heads
- Regional/Affiliate RA Heads
- Regional/Affiliate Managers
- Regional/Affiliate Associates
- CMC&Medical devices department
- Labeling department
- RSOs
- Regulatory Excellence teams
Occasional Contact with:
- Supply chain
- Business units
- EXTERNAL
Would be expected to be involved with:
- Vendors/service provider
SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS
:
Education Level:
- Physician, Pharmacist, Veterinarian or Scientific background with preferably Regulatory Affairs Master Degree
Experience:
- Minimum of 2-3 years experiences in, Regulatory Affairs,.
- High level technical knowledge about local requirements for post approval changes
- Previous exposure to Biologic/vaccine or both.
- Previous experience in local/multinational companies
- Have a good relation and proven record of success with local regulatory agency
Skills:
- Project management experience in the pharmaceutical industry or in a regulatory environment.
- Recognized expert in working with matrix teams.
- Knowledge in regulatory requirements and Good Manufacturing practices of the Country /Region
- Demonstrated ability to independently supervise or support regulatory teams and implement team objectives and strategies.
- be a business partner for Global CMC&Devices, Global Labeling, RSOs
- represent the regulatory position to senior management if needed
LEAD competencies:
- Act for Change
- Strive for results
- Cooperate Transversally
- Commit to Customer
- Think Strategically
- Make Decisions
Job Details:
Job/ Career : COE Regulatory Affairs Specialist
Posting-Date: 13/4/2020
Location: Cairo, Egypt
Company: Sanofi
Contract Type: Full time
Learn More about Sanofi:
سانوفي وهي شركة فرنسية ذات مناشئ عالمية مختلفة مقرها في باريس، فرنسا . تعمل سانوفي في البحث والتطوير، صناعة وتسويق الأدوية ..........( لمعرفة المزيد عن الشركة زورنا من خلال Meetup بالاسفل )
المقر الرئيسى : باريس , فرنسا
العنوان فى مصر : الأميرية الشمالية، الزيتون، محافظة القاهرة
العنوان فى السعودية: نجود سنتر ، جدة ، المملكة العربية السعودية
العنوان فى مصر : الأميرية الشمالية، الزيتون، محافظة القاهرة
العنوان فى السعودية: نجود سنتر ، جدة ، المملكة العربية السعودية
مواقع التواصل الاجتماعى الخاصة بهم :
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