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Job description / Role
The Regulatory Excellence Strategic Initiatives Manager is responsible for the development and implementation of consolidated strategies to secure and preserve market access of the Companys products throughout all the phases and post-approval life-cycle management.
The position is also responsible for the management and mentoring of Regulatory Leads with their strategic inputs for their assigned product/indication and leadership of the tactical regulatory management of their projects. Reviews and approves all the strategic regulatory documents used to support strategic regulatory discussions with health authorities.
Main Responsibilities:
- Responsible for establishing promoting and evaluating the excellent strategic initiatives in the Companys Regulatory Affairs operating environment.
- Leads the implementation of the Document Management Guidelines to archive all submissions and associated documents.
- Maintains and safeguard advanced corporate data base of all dossiers submitted approved for future reference.
- Provides regulatory strategy/requirements for new markets as well as innovative business ideas.
- Monitors the monthly Regulatory Affairs performances as per the department objectives.
- Cooperates with Regulatory Affairs team in the design and development of excellent strategic initiatives for client projects or to answer client inquiries.
- Collaborates with the Regulatory Affairs Strategic group in providing support and inputs for projects based on past therapeutic experience, global and local regulatory expertise.
- Maintains knowledge of the current regulatory environment by reviewing and communicating current 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.
- Presents regulatory affairs expertise and support the business development in either internal or external clients.
- Organizes task forces to address special Regulatory Affairs / Business needs.
Requirements
- Must have a degree in Life Science, Pharmacy or equivalent. Masters degree is an advantage.
- Experience in discovery research, preclinical pharmacology, toxicology, or clinical research preferred.
- Experience with leading strategic planning, preparation, and execution of Agency interactions.
- Has experience in successful submission, approval, and post-approval management in health agencies.
- Full functional knowledge of regulatory requirements (Directives, Regulations, and Guidance) pertaining to the development and registration of drug products.
- Has strong knowledge of regulatory guidance in multiple regions and industry best practices for drug development.
- Excellent organization skills and ability to manage multiple highly confidential projects.
- Proven history of finding solutions to challenging drug development issues and developing innovative regulatory strategies.
- Excellent communication and negotiation skills.
- Excellent understanding of pharmaceutical development, clinical research, study design, biostatistics, pharmacokinetics, regulatory environment, project management and medical terminology.
About the Company
Julphar is a true reflection of Ras Al Khaimah’s significant development. Established in 1980 under the guidance of H.H Sheikh Saqr Bin Mohammed Al Qasimi, we have established ourselves as a leader in production and distribution of pharmaceutical products.
Our goal is to create high-quality medicines whilst maintaining a competitive cost. We achieve this through a network of twelve world-class manufacturing plants (with further expansion planned) and a reliable logistics network which covers five continents.
We maintain a diverse product portfolio which target major therapeutic segments including endocrinology, anti-infective, cardiovascular and gastroenterology, over-the-counter, nephrology, dermatology, respiratory, metabolic and burn and wound management.