*Purpose: Responsible for compilation and submission of new registration dossiers to respective
countries as per the registration plan
\xef\x82\xb7 Handle the queries by providing the appropriate responses, as it is required to get the
approvals from the health authorities of different countries.
\xef\x82\xb7 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.
\xef\x82\xb7 Provide responses for the queries received from the Health authorities:
\xef\x82\xb7 Coordinate with the Regulatory agents in countries, distributor and other concerned
departments in order to fulfil the registration requirements.
\xef\x82\xb7 Update product specific APQR sheet which comprises of complete approved information
related to product at the time of the approval in the related market.
\xef\x82\xb7 Ensure compliance with submission/approval annual plans
\xef\x82\xb7 Ensure that all state and International regulatory requirements are addressed for the
marketed products and New Product submission.
\xef\x82\xb7 Lead to provide the Document Management Guidelines in support private markets for
different entities.
\xef\x82\xb7 Maintains knowledge of the current regulatory guidelines environment by reviewing and
communicating current decrees policies/practices issued by Health Ministry.
\xef\x82\xb7 Creates and builds confidence by representing the excellent strategic function of the
Company positioning as a preferred source for regulatory strategy expertise.
Core Competency
\xef\x82\xb7 In terms of competency you are highly result oriented with strong sense of accountability &
ownership.
\xef\x82\xb7 High on communication, interpersonal and decision skills required.
\xef\x82\xb7 You must have excellent understanding of Pharmaceutical Business and Planning skills.
\xef\x82\xb7 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
\xef\x82\xb7 Ability to multitask, prioritize and easily adapt to changing situations.
\xef\x82\xb7 Strong detail \xe2\x80\x93 oriented and must be highly organized, disciplined & motivated.
\xef\x82\xb7 Should be ready and willing to learn new things and implement them at workplace commit towards
work & added tasks
\xef\x82\xb7 Excellent in teamwork, collaboration and demonstrated ability in working independently and as
part of a team *Education: 4 years Bachelor Degree in Pharmacy / any equivalent field. *Experience: At least 7 - 9 years\xe2\x80\x99 experience in similar organization in pharma / Health care / Medical Industry. 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. Job Type: Full-time Ability to commute/relocate:

• Ras al-Khaimah: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor\'s (Required)

Experience:

• related: 9 years (Required)