Regulatory Affairs Manager

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

Primary Job Function

• Work closely with global and local colleagues to advise and agree on regulatory strategy, clinical development plans , marketing plan as well as data requirements
• Manage regulatory submissions process and their compliance with regulation, prepare high quality submission packages and responses for clinical trials, new product license applications and variations, annual updates within applicable timelines
• Monitor and influence assessment process to expedite and optimise the outcome of their submissions, to ensure submissions are made in accordance with accepted regulatory standards within appropriate timeframes.
• Lead, maintain and develop communication with Regulatory Authorities and Regulatory consultants, drive negotiations to ensure best possible product labelling and delivery of their commitments and deadlines
• Proactively build relationships externally and internally, work closely and swiftly with cross functional teams to address critical issues
• Communication of any regulatory changes to the business as necessary
• Creation, submission and maintenance of official local drug information, including Patient Information Leaflets, and packaging texts
• Ensure promotional activities are compliant to relevant legislation, implement and ensure systems are established and maintained for Regulatory Affairs Document Management
• Participate in safety reviews for implementing appropriate safety updates, lead audit activities for regulatory function as required
• Other job related tasks as assigned

Minimum Education

• A Bachelor’s degree or above in pharmacy, biology, chemistry, pharmacology or related life sciences is required

Minimum Experience/Training Required

• Industry experiences : A minimum of 6 years experience required in Regulatory, R&D or related area
• Position experiences :
• 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
• Other Special requirement :
• 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