Philips Head Regulatory Affairs- ISC 

India, Haryana 

354864565

Head of Regulatory Affairs- ISCJob Description

Head of Regulatory Affairs

Additional representative responsibilities will include, but not necessarily be limited to, the following:

• To formulate and implement the Businesses and / or Markets long-range regulatory strategies and policies.Define the direction for ISC regulatory activities and develop short, medium and long-term action plans to fulfil the Growth Region strategy.
• Ensure the ISC RA teams are aligned to the strategy and are supportive of the company's global and regional objectives.
• Build leadership and functional capability within the teams to keep pace with the changing science and regulatory environment, as well as managing departmental resources in line with changes in portfolio volume and priorities.
• Be accountable for the planning and execution of RA strategies for medical devices and solutions across India Subcontinent (ISC) Zone.
• Responsible for the coordination and preparation of relevant ISC regulatory submissions consistent with regulatory requirements to meet corporate strategy & timelines.
• Provide regulatory input into cross-functional Team and Global colleagues for product development, submission and post marketing activities.
• Create regulatory awareness level as determined within the organization.
• Enforce a simplified yet robust regulatory processes and harmonizes them across the Clusters and Businesses and Markets and Functions, establishing an effective Management Review process, including routine reporting.
• Introduce and implement the necessary regulatory processes and tools required to ensure first time right in submissions.
• Manage compliance to relevant regulations and other Regulatory Requirements and as required, guidelines and policies to all products and operations are consistent with those regulations.
• Lead the Planning, generation, and coordination of regulatory submissions for product/solution licensing.
• Provide regulatory review and approve of internal documentation supporting product development and post marketing activities.
• Act as primary contact for India CDSCO and subcontinent Regulators (primary lead for all regulators meetings and related activities)
• Monitor the development of new requirements or regulatory procedures.
• Coordinate with consultants and other external stakeholders assisting with submission activities.
• Maintain ISC regulatory project logs, tracking the submission status of reports and other regulatory activities.
• Participate, facilitate relationship with industry forums across ISC and globally.

You are a part ofYou are part of Growth Region Regulatory team. Reporting line of this position is to Director RA Growth Region. You will have exposure to a multitude of medical devices, Business groups and sites and workflow solutions and services. This position partners with business leaders, marketing, quality, and legal among other functional areas where you will guide the related stakeholders in application of all applicable regulatory requirements, ensuring gap analysis, regulatoryassessment and impact for a successful regulatory submission and approval in each impacted country.

Qualifications

• Bachelor’s degree (scientific or clinical background desirable) required; advanced degree preferred.
• Minimum 10+ years of Regulatory Affairs experience in the medical, pharmaceutical or biotechnology industry.
• Minimum of 5+ years of people management – direct & indirect
• Strong knowledge of appropriate regional and global medical device regulations, requirements and standards.
• Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter.
• Strong interpersonal skills to collaborate effectively across multiple functional areas.
• Excellent/business level communication skills in both verbal and written.
• Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
• A bias towards action combined with high ethical standards is essential.
• Initiative, combined with a high energy level is critical to success.
• Must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.
• Experience in assembling the technical documentation files or design dossiers (at least 3 years)
• Strong project management skills
• Ability to interpret applicable regulations to ensure compliance in a changing regulatory landscape
• Ability to work nimbly, innovative approach to problem solving
• Ability to work in a matrix organization and being agile
• Strong organizational skills, ability to work on multiple projects, and work effectively in a demanding, time-sensitive environment

Competencies:

• Leadership/management experience
• Ability to understand regulatory environment
• Ability to understand, interpret and deploy compliance rules, guidelines and regulations
• Ability to partner with other areas of Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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