Job Details
Skills And Tools:
Job Description
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.
Senior Regulatory Affairs Specialist Vacancy:
We are recruiting a professional marketer to join the team as RA Specialist responsible for follow up and update on DKT's pipeline registration. The details of the opening are as follows:
- Designation: Senior Regulatory Affairs Specialist
- Location:Nasr City HQ
- Job Grade:R01/R03
- Reporting:Deputy Country Director
Job Purpose:
The Regulatory Affairs Specialist acts as a link between the company and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation and versus plan timelines
A. Essential Duties and Responsibilities:
- Plan the review of a new application submission corresponding to company plan as well as the agency guidelines for submission.
- Plan for the review and submission of all the maintenance activities (renewal & variations) based on company plans and the agency guidelines
- Timely implementation of all plans with strict follow up with both internal & external stakeholders for timely achievement of the plan.
- Maintain the products labeling up to date, implementing global and local labeling decisions, through labeling, review and approval
- Updating the internal DKT DMFs regularly
- Revision and approval of promotional Materials any updated packaging material on VISTA
- Preparation, submission and follow up of pricing files internally and externally
- Following and complying with all the defined internal policies and procedures of working
- Following strictly all the Authority Regulations, decisions & decrees
- Carry out all the required communication and follow up required with local affiliate, region & corporate as appropriate.
- Carrying the planned Activities and reflecting the approvals on the internal system
- Revision and approval of Promotional Materials & any updated packaging material
- Perform other duties as assigned.
- Respect of company’s values, code of ethics and social charter.
- Respect of personal data protection charter
Job Requirements
B. Qualification/Knowledge/Experience:
- Level of education:Bachelor of Pharmacy ONLY
Experience :
- Previous experience of dealing with regulatory authorities for at least a year is mandated (1 years of experience in similar position in different types of registrations, preferably in multinational organization)
- Experience of registration of Medical Products is essential
- Knowledge of Pharmacovigilance and CTDis desired
- Language :Fluent English proficiency is mandated
- IT Literacy :Professional knowledge of MS-Office
C.Special Knowledge/Skills:
- Negotiation & communication skills
- Organization skills and high accuracy in documentation
- High sense of urgency
- Priority setting and management
- Knowledge of new decrees & guidelines
- Multitasking
- Awareness and adherence to company internal SOPs & compliance standards
- Promptness in respond to authorities’ requirements and prompt in deliverables
- Analytical skills
- Ability to alert hierarchy in case of specific situation impacting his/her work environment
- Problem solving skills
- Presentation skills
- Interpersonal skills
- An understanding and appreciation of relevant legal, scientific and manufacturing area
D. Competencies and Behaviors:
- Act for Change
- Strive for results
- Cooperate Transversely
- Commit to Customer
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!
- For the selected candidates, we offer a superb working environment and a challenging atmosphere.
- You can also look forward to a competitive salary and benefits package with room for talents and potential candidates to sharpen and advance their career forward supported by exposure, learning and development opportunities.
Please visit us:
- www.dkteg.com
- https://www.dktinternational.org
- 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
