Team Leader

Job Title: Team Leader Division: REGULATORY AFFAIRS Country: UNITED ARAB
EMIRATES Work Location: UAE (RAK head office) Job Type: Team Leader Employment
Type: Full Time Employment (Un-limited Contract) Job Description:* *
Purpose: Responsible for compilation and submission of new registration
dossiers to respective countries as per the registration plan  Handle the
queries by providing the appropriate responses, as it is required to get the
approvals from the health authorities of different countries.  Evaluation and
identification of documentation gaps during the dossier compilation and
communicating with the respective department to fulfil requirements. Key
responsibilities & Accountability: Prepare the Registration dossiers for the
Health authorities in different countries as per their current guidelines. 
Provide responses for the queries received from the Health authorities: 
Coordinate with the Regulatory agents in countries, distributor and other
concerned departments in order to fulfil the registration requirements. 
Update product specific APQR sheet which comprises of complete approved
information related to product at the time of the approval in the related
market.  Ensure compliance with submission/approval annual plans  Ensure
that all state and International regulatory requirements are addressed for the
marketed products and New Product submission.  Lead to provide the Document
Management Guidelines in support private markets for different entities. 
Maintains knowledge of the current regulatory guidelines environment by
reviewing and communicating current decrees policies/practices issued by
Health Ministry.  Creates and builds confidence by representing the excellent
strategic function of the Company positioning as a preferred source for
regulatory strategy expertise. Core Competency  In terms of competency you
are highly result oriented with strong sense of accountability & ownership. 
High on communication, interpersonal and decision skills required.  You must
have excellent understanding of Pharmaceutical Business and Planning skills. 
Must have analytical mind and ability to analyze, summarize data and must be
able to communicate technical, scientific, and regulatory information, both
written and verbally  Ability to multitask, prioritize and easily adapt to
changing situations.  Strong detail - oriented and must be highly organized,
disciplined & motivated.  Should be ready and willing to learn new things and
implement them at workplace commit towards work & added tasks  Excellent in
teamwork, collaboration and demonstrated ability in working independently and
as part of a team Qualifications: - Education ‎4 years Bachelor Degree in
Pharmacy / any equivalent field. - Experience: At least ‎5-‎6 years' experience
in similar organization in pharma / Health care / Medical Industry. -
Training: Key Competencies: Fluent in English & Arabic (communicating, writing
and speaking).  Proficient in MS Office (MS Excel and MS Word, etc.). 
Proven experience in reporting and authoring complex scientific documents,
producing high quality clinical/regulatory/scientific / medical documents.
Technical Competencies: