Regulatory Affairs Manager

at  Cipla

ACCOUNTABILITIES:

• Provide regulatory Intelligence to Cipla RA Managers/Executives/ RA Director and CEO. Provide insight into impact to business and strategies to adapt
• Ensure pre-launch stage product submission and registration activities
• Ensure dossier life cycle management registration activities by ensuring the following activities are conducted
• New Business Development Implementation
• Support and enable delivery of Regulatory Affairs Pharmacists/Scientists
• Develop and manage stakeholder relationships
• Lead and develop the regulatory affairs team

QUALIFICATION & EXPERIENCE:

• B Pharm or higher (postgraduate)
• Min. 5-10 years’ experience in regulatory affairs covering all areas of the function. At least 2-3 years’ experience in managing others. Proven skills in Business acumen, People Management experience, Negotiation and influencing skills and a collaborative approach

• Manage submissions to different Health Authorities within the Regulatory Affairs function by ensuring targets are met each financial year
• Manage registrations and engagement with the different Health Authorities to ensure targets are met w.r.t. registrations and launches
• Manage every aspect of product Life-Cycle management within the Regulatory Affairs function by ensuring that the dossiers submitted and registered are up to date with any changes or variations in order to ensure dossier compliance and maintenance and minimize risk. Ensures that administration related to the Management of these processes are conducted according to departmental procedures for all products
• Lead a group of RA Pharmacists/Scientists directly in all aspects related to objectives and delivery thereof.
• Provide RA Intelligence to RA Executive and RA Director on all projects and processes related to key objectives