Regulatory Affairs Supervisor - Pharmaceutical

A. Essential Duties and Responsibilities:

• Contribute to the formulation and execution of regulatory strategies for Multicare's portfolio, proactively seeking innovative and rapid path to market. Use internal and external networks to ensure regulatory strategies are robust and keep pace with the regulatory environment
• Act as one of the RA advisors on the applicable regulations that govern products in remit, provide guidance and considering all possible interpretations and regulatory pathway
• Keep updated the local registration tracking of all new/ongoing applications, renewals and variations for the assigned products, and corresponding related databases/systems
• Provide Regulatory Affairs program governance, administration, business attestation review, metrics/reporting, and training
• Manage, maintain and communicate relevant policies, standards and procedures
• Communication with responsible regulatory authorities (national/international) as well as with notified bodies
• Ensure that a company's products comply with the regulations of the regions where they want to distribute them
• Provide support for all external audits Accountability, including audit corrective and preventive action plans (CAPAs).
• Collect, collate and evaluate scientific data from a range of sources
• Prepare submissions of license variations and renewals to strict deadlines
• Project manage teams of colleagues involved with the development of new products
• Negotiate with regulatory authorities for marketing authorization
• Take part in the development of marketing concepts and approve packaging and advertising before a product's release
• Act as the contact point for colleagues within the company in terms of all questions concerning the technical documentation and the approval of products
• Examine the conformity (all documents for approval must be compliant to all relevant regulations, rules and standards) and taking part in the conformity assessment procedures with coordination of all concerned departments
• Enhance existing engagement model and serve as a trusted business partner representing the Regulatory Affairs organization to business functions, business lines, and other stakeholders
• Act as internal advisor on existing and emerging trends for products/categories in remit. Anticipate threats and opportunities. Interpret regulatory actions and provide the business and R&D with robust analyses and recommendations for action

Job Requirements

B.Qualification/Knowledge/Experience:

• Level of education:A Degree in Pharmacy is ESSENTIAL
• Experience:≥ 3-5 years work experience in Regulatory Affairs function within pharmaceutical sector
• Language:English proficiency is mandated
• IT Literacy:Professional MS-Office knowledge

C.Competencies and Behaviors:

• Professional networking and MoH access
• Ability to work under sustainable pressure and handling of simultaneous tasks to meet timeline
• Strong planning and organization capabilities
• Ability to influence, convince and persuade
• Strong sense of accountability and autonomy
• Negotiation skills
• Must be flexible and adaptable to change