Regulatory Affairs Manager CONTRACTOR 1 YEAR

Full time na a Laimoon Verified Company no UAE

Publicado em December 1, 2024

Detalhes do emprego

The Regulatory Affairs Manager will lead, manage, and provide strategic direction and oversight to the Head of Regulatory Affairs and above regulatory teams to develop and execute regulatory strategies and plans for the country.Job Responsibilities:Manage the assigned portfolio in the development of regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations, and lifecycle management. Provide strategic regulatory input into global regulatory strategies, thus providing optimal support for meeting local business objectives under Country Regulatory Head lead.Develop strong partnerships with in-country (e.g., BU leads, Market Access, Marketing, Supply Chain) and with above country (e.g., Country Strategists, GCMC Hub, Submission and labeling/artwork Hubs, Therapeutic Area and Regional Teams) to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions, and life-cycle optimization.Responsible for their own personal development, leadership, and performance to achieve company objectives and agree training and development needs with Country Regulatory Heads to develop and enhance individual capabilities and capacities.Responsible for developing and enhancing relationships with key external agencies (HA's/BoH, Regulatory KOL's, etc.). Manage the HA/BoH interface throughout the development and lifecycle of a product.Maintain licenses (e.g., Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP's, and systems are followed ensuring training in P2L are completed 100% (systems and procedures).Maintain compliance at 100% in all regulatory systems. Where needed, oversee and manage the completion of CTA, NDA, and Lifecycle (LC) submissions and approvals as per established EM performance metrics.Skills:Understanding of regulatory agency philosophies, culture, and developing trends in the regulatory environment. Experience in preparing and submitting CTA's, NDA's, variations, and LC submissions. Working with and influencing opinion leaders, external organizations, and CRL's facilitating approval of submissions. Is driven to continually enhance regulatory expertise, both locally and globally.Knowledge of drug development practice, rules, regulations, and guidelines.Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to Regional regulatory strategies and implementation plans. Maintains internal and external networks to learn in advance about new regulatory trends or changes impacting the Regulatory, Medical, and overall Business strategy.Strategic Thinker: Provides strategic contribution and anticipates what RA needs to contribute to develop and achieve business objectives. Effectively explores alternative regulatory strategies and positions to reach outcomes that gain the support and acceptance of all parties.Communication skills: Clearly conveys information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand the message.Negotiation skills: Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations. Has built a strong relationship with the local health agency and other relevant stakeholders (regulatory KOL's) and pro-actively manages issues with the HA's and other key external stakeholders.Problem Solving: Effectively identifies issues and challenges and works with partner groups to identify options and implement agreed upon solutions.Detailed Oriented: Can be thorough and complete with high quality.Project Management: Can manage complex and multiple projects.

#J-18808-Ljbffr Management & Operations

Apply safely

To stay safe in your job search, information on common scams and to get free expert advice, we recommend that you visit SAFERjobs, a non-profit, joint industry and law enforcement organization working to combat job scams.

Hiring company

Confidential

Improve your chance to get this job. Do an online course on Saúde e Segurança starting now.

Health and Safety Certificate Level 2 Alpha Academy

AED 92
~~AED 1,543~~

Duração: Upto 8 Hours

Enrol
Asbestos Awareness New Skills Academy

AED 88
~~AED 1,098~~

Duração: Upto 2 Hours

Enrol

See all courses

See All Regulatory Jobs

Regulatory Affairs Manager CONTRACTOR 1 YEAR

Detalhes do emprego

Apply safely

Hiring company

Confidential

Manager - EIT & Integration Engineering

Project Engineering Manager

Bid/ Tendering Manager

HR Manager

Asset Manager

Talent Management Lead

Architectural Engineer Level II

Sr Electrical Engineer

RBI Team Lead (Fixed Term - 24 Months)

Senior RBI Engineer (Fixed Term - 24 Months)

T&I Senior Engineer - Offshore

Senior Architectural Engineer

Senior Architectural Engineer

Jr Drilling Engineer

Senior Instrument Designer

Senior HVAC Designer

Senior Civil Designer

Empregos

Cursos/Formação

Localização

Follow us

Início EAU Regulatory Affairs Manager CONTRACTOR 1 YEAR

Início EAU Regulatory Affairs Manager CONTRACTOR 1 YEAR

Regulatory Affairs Manager CONTRACTOR 1 YEAR

Detalhes do emprego

Apply safely

Hiring company

Confidential

Similiar Jobs that might interest you

Manager - EIT & Integration Engineering

Project Engineering Manager

Bid/ Tendering Manager

HR Manager

Asset Manager

Talent Management Lead

Architectural Engineer Level II

Sr Electrical Engineer

RBI Team Lead (Fixed Term - 24 Months)

Senior RBI Engineer (Fixed Term - 24 Months)

T&I Senior Engineer - Offshore

Senior Architectural Engineer

Senior Architectural Engineer

Jr Drilling Engineer

Senior Instrument Designer

Senior HVAC Designer

Senior Civil Designer

Porque está a reportar esta oferta?

Laimoon Job Alert fresh jobs directly from websites*

Empregos

Cursos/Formação

Localização

Follow us