Regulatory Affairs Officer

الوصف الوظيفي
POSITION SUMMARY:

The Regulatory Affairs Officer is responsible to provide input as required at all levels within the AHC, the

main responsibility is to plan and execute all activities necessary for the registration of new products and

line extension indications. The Regulatory Affairs Officer ensures the appropriate licensing, marketing

and legal compliance of pharmaceutical and medical products. Also assist in the releases required for all

company products .

ESSENTIAL DUTIES:

1 Ensuring that a company's products comply with the regulations of the Medicines and Healthcare

products Regulatory Agency (MHRA).

2 Responsible for Pharmacovigilance activities as Qualified Personal for Pharmacovigilance.

 Review all distribution agreements in this regards.

 Collection of Adverse event reports.

 Notify the MOH and Principals for any adverse event (AE).

 Monitoring of any PV regulations.

 Training employees on PV.

3 Keeping abreast of international and local legislation, guidelines and customer practices.

4 Collecting and collating a wide range of information, keeping up to date with a company's product

range.

5 Developing and writing clear point of view and explanations for new product license and licenses

renewals.

6 Preparing submissions of license variations and renewals; setting timelines for license variations

and renewal approvals.

7 Understanding and evaluating complex information and planning and developing product trials;

interpreting trial data and advising company’s on regulatory requirements;

8 Resolving complex issues as arise; preparing and coordinating documentation;

9 Project managing teams of colleagues involved with the development of new products;

maintaining quality systems; undertaking and managing regulatory inspections;

10 Reviewing company practices and providing advice on changes to systems;

11 Liaising with, and making presentations to, regulatory authorities; submitting license and clinical

trials applications to authorities to strict deadlines;

12 Negotiating with regulatory authorities for marketing authorization.

13 Specifying storage, labeling and packaging requirements, liaising closely with the regulatory

authorities on a regular basis.

14 Review of validation, development and stability reports to ensure compliance with licence details

and relevant guidelines and directives.

15 Assist in the training of new artwork and regulatory personnel.

16 Communicate with all departments/division to ensure schedules are achieved. Provision of

regulatory support.

17 Negotiate and ensure the best listed prices for the priced products

18 Assist in all types of releases required for the company products

19 Make recommendations relating to general improvements of the business.

20 Attend external meetings/training courses to maintain/improve overall knowledge of regulatory

procedures, guidelines and directives.

21 Complete any other duties as considered necessary by the Company and directed by

immediately Supervisor.

المهارات
POSITION QUALIFICATIONS:

Minimum Education : :Preferably with Bachelor Degree in Pharmacy or any medical field, with

broad scientific knowledge to allow understanding of chemistry/pharmacy,

preclinical and clinical data issues.

Minimum Experience : 5 years experience in the pharmaceutical or related industry and 2 years

of Regulatory Affairs or Regulatory Compliance with experience in

dealing with Local Government Authorities.

Skills :

Good oral & written communication skills.
good organization and time management/project management.
ability to work effectively within a team.
ability to operate in multi-function environment.
attentive to details, adaptive and flexible.
Knowledge of the regulatory requirements for the Medical Company industry To produce clear.
concise, reports to a variety of different people.
To work concurrently on multiple projects agreed time scales.
ability to work with all types of individuals in multiple settings and locations and to promote diversity in the workplace. Must be able to prioritize and work effectively in a constantly changing environment.
تفاصيل الوظيفة
منطقة الوظيفة الكويت, الكويت
قطاع الشركة خدمات الرعاية الصحية الأخرى
طبيعة عمل الشركة صاحب عمل (القطاع الخاص)
الدور الوظيفي التمويل والإستثمار
نوع التوظيف دوام كامل
الراتب الشهري غير محدد
عدد الوظائف الشاغرة 1
المرشح المفضل
عدد سنوات الخبرة الحد الأدنى: 5
منطقة الإقامة الكويت
الشهادة بكالوريوس/ دبلوم عالي

https://www.bayt.com/ar/kuwait/jobs/regulatory-affairs-officer-4619587/