Position Summary

Director – GAMA & RA will report to the Vice President and General Manager, India and will be a key member of the India commercial leadership team.

Director – GAMA & RA will be responsible for leading and providing oversight to the Regulatory and Government affairs function.

Director – GAMA & RA will work closely with India leadership team, APAC commercial team, Divisional RAQA,and GAMA leaders.

Essential duties & responsibilities:

Government Affairs

• Be a custodian of Stryker’s brand among key Government stakeholders, academic institutions, trade associations and industry peers
• Identification, engagement, coordination, and representation with stakeholders in the public policy ecosystem to bring forth Stryker’s position with the relevant external stakeholders on policy areas of impact.
• Identify, Analyze, develop positions, and drive advocacy on policy and regulatory issues pertinent to Stryker’s business in India.
• Work with cross functional teams to develop positions around medical device policy, Innovation and R&D, trade & pricing
• Develop and manage trusted relationships with key influencers or experts, Government officials, academia, industry peers and Trade associations.
• Continuing to strengthen and build Market access and Health economics capabilities
• Work closely with teams engaged in CSR, Communications and Marketing to plan and support interactions and events that engage external government and industry leaders to support Stryker’s Corporate Responsibility initiatives
• Work with both internal and external stakeholders to gather information and attend to any issues that affect/ impact Stryker’s business operations
• Build relationship and network with regional and global GA teams

Regulatory affairs

• Establish, optimize and execute India Regulatory strategies
• Build and maintain good relationships with CDSCO/India regulatory bodies and industry associations to achieve optimal outcomes for approval of new products and maintenance of existing products.
• Lead the registration strategy and process for existing and new products planned to be launched in India
• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
• Develop and lead the annual New product submission planning process in collaboration with commercial leaders
• Build regional and global network and relationships to ensure adequate/required support for meeting registration timelines
• Develop and execute 5-year regulatory affairs strategy
• Identify and lead process improvement opportunities and also participate in global process improvement initiatives as lead for India
• Lead product field action/recalls if any
• Be the lead for all things relating to RAQA and GA for global team
• Partner with Commercial teams on BD/M & A activities

Qualifications & experience:

Qualifications:

• Master of Pharmacy or equivalent Master degree in relevant field

Experience:

• Typically, a minimum of 12-14 years’ experience
• 5 plus years of people management or 2-3 years of leadership exp
• Medical device/Healthcare experience a must

Work Knowledge, skills & abilities

• Strong interpersonal skills, problem solving character
• Very hands-on, Process driven and ability to stay focused and delivering high quality outcomes
• Team player, Inclusive and collaborative
• Forceful in decision making process
• Good communicator
• Results oriented with the determination and perseverance to drive results within a matrix environment and globally oriented company
• Ability to build relationships and collaborate at all levels of the organization and across multiple functions
• Strong financial and analytical skills
• Absolute personal integrity and honesty.
• Operate effectively in a multi-disciplinary matrix environment
• Willingness to accept variety of assignments, highly motivated, with a natural ability to perform under stress
• Project management, writing, coordination, and execution of regulatory items
• Self starter and comfortable taking lead