Job Ref. ID:
Team Leader – RA
UNITED ARAB EMIRATES
UAE (RAK head office)
RA - Team Leader
Full Time Employment (Un-limited Contract)
Job Summary/ Main Purpose
As a Team Leader RA will act as subject matter expert for all the regulatory compliance requirements and submissions. The role holder is expected to adhere with cGMP principles and to maintain them in an effective manner, develop monthly & annual plan to ensure regulatory compliance for products licenses renewals and other related activities in the functional areas of responsibility.
Responsible to maintain and safeguard advanced corporate data bases of all dossiers submitted & approved for future reference. Maintain knowledge of the current regulatory environment by reviewing and communicating current policies/practices issued by Health Ministries. Organize task forces to address special department needs, provide input to strategies decisions that affect the functional areas of responsibility and develop reports for managements detailing the regulatory affairs. You should be capable of resolving escalated issues arising from operations and requiring coordination with other departments.
Key responsibilities & Accountability:
Key Responsibilities & Key Result Areas
• Lead and support Regulatory Staff to ensure compliance with submission/approval annual plans for renewal and post approval changes and ensuring submission and approvals in Ministry of health on timely basis.
• Responsible for the overall compilation of regulatory submissions to the Health Authorities, drafting Product Information, Clinical Information, literature searches to support submissions, product analysis, changes in manufacturing, pack sizes, CPI and PIL development, packaging changes, notification and other regulatory activities.
• Develop strong partnership with stake holder department and commercial teams to facilitate the development and implementation of registration strategies to enhance the portfolio.
• Understand country needs and works to improve the quality of the database holding change requirement.
• Coordinate with the Regulatory affiliates in countries, distributor and other concerned departments in order to fulfil the registration requirements.
• Liaise with specialized individuals and sections within RA to fulfil authorities queries and additional requirements.
• Lead to provide the Document Management Guidelines in support of private markets for different entities.
• Maintain knowledge of the current regulatory guidelines environment by reviewing and communicating current decrees policies/practices issued by Health Ministry.
• Create and build confidence by representing the excellent strategic function of the Company positioning as a preferred source for regulatory strategy expertise.
• Investigate opportunities for regulatory innovation / promote the use of novel approaches within team to resolve issues and problems.
• Resolve complex issues and manage regulatory risks and ambiguous situations within the regulatory teams.
• Responsible for planning of submissions, approvals on monthly, quarterly and yearly basis for allocated markets
• Train and coach the team on regulatory technical skills whenever needed
• Preform any other work assigned by Manager and support colleagues whenever necessary.
• In terms of competency you are highly result oriented with strong sense of accountability & ownership.
• High on compliance with strong attention to details required.
• Good organization ability and implementation skills.
• You must have excellent understanding of Pharmaceutical Business with strong influencing skills
• Strong communication, interpersonal, decision skills required
• Must have a solution centric mind to understand issues and solve them within a stipulated time frame, ability to understand new issues quickly and make wise decisions.
• Ability to work under pressure, plan personal workload effectively and delegate.
• Motivated and highly organized professional and should be able to juggle competing priorities.
• 4 years Bachelor’s degree in Pharmacy or any related field.
• Master degree in Pharmacy is recommended.
• At least 6 -8 years’ experience in Regulatory Affairs in pharmaceutical industry.
• Should have handled similar role for a better fitment of this role.
• Fluent in English is mandatory (communicating, writing and speaking).
• Proficient in MS Office (MS Excel and MS Word, specifically) applicable database and compliance software.
• Proven experience in successful submission, approval, and post-approval management in health agencies.
• Proven experience of finding solutions to challenging drug development issues and developing innovative regulatory strategies.
• Extensive knowledge of regulatory guidance in multiple regions and industry best regulatory practices.
• functional knowledge of regulatory requirements (Directives, Regulations, and Guidance) pertaining to the development and registration of drug products.
Copyright, All Rights Reserved | Julpharcareers 2020