Job Details
Skills And Tools:
Job Description
DKT's Company Profile:
DKT International was founded in 1989 based in USA, to focus the power of social marketing on some of the largest countries with the greatest needs for family planning & HIV/AIDS prevention. By doing so, DKT has achieved tremendous health impact, and done it cost-efficiently.
DKT is one of the largest private providers of family planning products in the world, having generated over 36,652,368 couple years of protection (CYPs) in 2017. As of 2017, DKT has offices in 24 countries, with a sales presence in 33 countries.
DKT started to serve the Egyptian community since 2005.
DKT Egypt program is 7th among 98 programs worldwide that serve family planning & prevention of HIV/AIDs. DKT Egypt distinctively serves Women’s Health & Family Planning, via provision of 12 products, as well as going the extra mile by: training service providers on reproductive health & contraception, as well as propagating awareness about the importance of family planning & educate women on the different contraceptive choices to meet the different needs. During 2018, DKT Egypt expanded into the MENA region, to serve and support more women in-need in this volatile region in the world.
DKT…. Family Planning & More.
Regulatory Affairs Manager VACANCY :
We are hiring a Regulatory Affairs Manager as per the following details:
- Job Grade: RA01/RA03
- Reporting to:Deputy Country Director
- Location: Cairo HQ - Nasr City
Job Purpose:
Drive all Regulatory Affairs activities to ensure delivering of the function KPI's that serve the overall business goals and strategic direction through securing approvals of new products agianst set agreed plans
A. Essential Duties and Responsibilities:
- Lead registration and re-registration process end-to-end at both DKT and Regulatory Authorities levels (MoH, NODCAR, etc)
- Provide responses to Regulatory Agencies regarding product information or issues
- Align Regulatory Affairs planning with business strategy and commercial objectives to ensure full synchronization and harmony
- Coordinate QPPV related tasks and responsibilities
- Develop and maintain standard operating procedures or local working practices
- Maintain current knowledge of relevant regulations, including proposed and final rules
- Manage activities such as audits, regulatory agency inspections, or product recalls
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes
- Oversee documentation efforts to ensure compliance with domestic and international regulations and standards
- Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards
Job Requirements
B. Job Requirements:
1.Qualification/Knowledge/Experience:
- Education :Must be Pharmacist (B.Sc. in Pharmacy)
- Experience :
- Two to four years of experience in a similar position; - Previous exposure to Planning and Supply Chain is a definite plus
- Experience supporting manufacturing/operations driven projects and achieving change approvals globally per business expectations
- IT Literacy :
- Proficiency in Microsoft Word, Outlook and PowerPoint
- Advanced Excel skills, ability to work with look-ups and pivot tables
- Language :
- English Proficiency both verbal and writing
2.Competencies and Behaviors:
- Strong understanding of product development process and ability to effectively partner cross-functionally
- Strong technical knowledge of medical products & terminology
- Excellent research and analytical skills
- Ability to manage multiple projects simultaneously
- Excellent written and oral communication, technical writing and editing skills
What we offer:
- With us, there are always opportunities to break new ground.
- We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons.
- We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life.
- Join us and bring your curiosity to life!
- You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn't cut it - you've got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you're known for your good nature.
- You'll fit right in at DKT Egyptwhere we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.
You can follow us through:
www.dkteg.com
https://www.linkedin.com/in/hr-dkt-46a20217b/
https://www.linkedin.com/company/dkt-egypt-mena/about/?viewAsMember=true
https://www.instagram.com/hr.dkt/
https://twitter.com/hr_dkt
