A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : DRA Compliance Manager
Job Description :
Globally responsible for monitoring Regulatory Compliance within DRA and across functions defined by critical control points for processes and procedures. Perform internal audit in DRA and in functions with process interfaces and thereby ensuring identification and resolution of compliance gaps and issues on an on-going basis. Support implementation of effective and efficient processes that fulfill regulatory requirements and expectations in a sustainable way.
• Give input to and support the global DRA Compliance strategy
• Responsible for a robust compliance monitoring system to ensure DRA regulatory compliance on an on-going basis; provides adequate tracking and oversight to any regulatory commitments and ensures their timely closure.
• Support regulatory risk management through identification, assessment, mitigation and communication of any potential regulatory compliance risks
• Monitors the effectiveness of the DRA self-inspection program; ensures review and approval of proposed CAPA activities for their effectiveness and timely closure
• Give in-put to and implement a robust Key Quality Indicator program to ensure that the compliance status and improvements are routinely monitored, assessed and reported. Utilizes the KQI program to identify continuous improvement opportunities.
• Ensures that regulatory processes and procedures at the Novartis CPO organizations meet regulatory and company expectations and are part of the on-going monitoring processes
• Support a compliance and quality culture within DRA through effective cross-functional team work and open communication
• Support implementation of new regulatory requirements by analyzing their impact on the company’s on-going compliance
• Escalate compliance status and potential compliance risks as necessary to DRA QA Management
• Work effectively within the Compliance team within DRA QA; supervises and manages consulting and/or temporary personnel
Candidate Profile:
Education (minimum): Scientific Degree in Life Sciences
Languages: Fluency in English, written and spoken. German is desirable
Experience:
• At least 5 years professional experience in Regulatory in the Pharmaceutical and/or Medical Device Industry
• Very good understanding of GXP Regulations and global Regulatory Guidelines
• Strong interpersonal and communication, negotiation and problem solving skills
• Good knowledge of the regulatory processes for drug de-velopment and regulatory compliance of marketed prod-ucts
• Ability to work globally to initiate and co-ordinate the work of associates at all levels
• Ability to communicate concepts and ideas verbally and in writing
• Excellent negotiation and interpersonal skills
• Ability to work effectively cross-functionally, in a team environment across cultures
• Considerable organization awareness (e.g. interrelation-ship of departments, business priorities) including experi-ence working cross-functionally and in global teams.
Additional Information:
Location: Hyderabad
Education: B.Pharm, M.Pharm
Work Location : Hyderabad
Industry Type: Pharma/ Biotech/global development
Functional Area: Development & Medical
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 100747BR
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