Global Regulatory Strategy Lead

Abbott; Virginia (MN); On-site; USD 120,000 - 170,000; Full time

Job summary

Abbott seeks a Regulatory Affairs professional to guide regulatory strategy and submissions across global and local teams. You will manage submissions for clinical trials, new product licenses, variations, and annual updates, ensuring compliance and timely delivery.

The role requires at least 6 years in regulatory/R&D with 4 years in pharma regulatory affairs, fluent English, and willingness to travel in a complex, matrixed environment.

Qualifications

• Industry experiences : A minimum of 6 years experience required in Regulatory, R&D or related area
• Minimum of 4 years experience preferred in pharmaceutical regulatory affairs.
• Having experience interfacing with government regulatory agencies and proven skill at developing and implementing successful China regulatory strategies.
• Experience in Woman Health, CV, Vaccine, etc. is a plus
• Language Skills：Fluent English both oral and written
• Mobility : May need travel
• Experience working in a complex and matrixed environment is required
• Dependent on individual aptitude with experience of a broad range regulatory work in the ethical pharmaceutical industry
• Management experience - Up to date knowledge of legislation

Responsibilities

• Advise and agree on regulatory strategy and data requirements with global and local teams
• Manage regulatory submissions and ensure compliance with regulations
• Prepare high quality submission packages and responses for clinical trials, new product license applications and variations
• Lead communications with regulatory authorities and regulatory consultants
• Develop and maintain labeling and packaging texts
• Ensure promotional activities are compliant with relevant legislation
• Participate in safety reviews and lead audit activities for regulatory function
• Other job related tasks as assigned

Skills

Regulatory strategy

Regulatory submissions

Stakeholder management

Cross-functional collaboration

Education

Bachelor’s degree or above in pharmacy, biology, chemistry, pharmacology or related life sciences

Job description

Abbott seeks a Regulatory Affairs professional to guide regulatory strategy and submissions across global and local teams. You will manage submissions for clinical trials, new product licenses, variations, and annual updates, ensuring compliance and timely delivery.

The role requires at least 6 years in regulatory/R&D with 4 years in pharma regulatory affairs, fluent English, and willingness to travel in a complex, matrixed environment.