Regulatory Affairs Project Manager

Regulatory Affairs Project Manager

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

We are seeking a Regulatory Affairs Project Manager to join our Lingo team in Alameda, CA. As an individual contributor, the function of a Regulatory Affairs Project Manager is to combine knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured, or distributed to meet required legislation. The individual has department / group / site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data, and ensure that they are effectively presented for the registration of products worldwide.

What You'll Work On :

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Develop new regulatory policies, processes, and SOPs and train key personnel on them.
• Evaluate regulatory risks of division policies, processes, procedures.
• Provide regulatory input to product lifecycle planning.
• Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management.
• Assist in the development of multicountry regulatory strategy and update strategy based upon regulatory changes.
• Assist in regulatory due diligence for potential and new acquisitions.
• Utilize technical regulatory skills to propose strategies on complex issues.
• Determine submission and approval requirements.
• Identify emerging issues.
• Monitor trade association positions for impact on company products.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Develop and mentor regulatory professionals.

Required Qualifications :

Background / Skills / Knowledge Regulatory Knowledge of (as applicable) :

Communication Skills or Ability to :

Cognitive Skills or Ability to :

Preferred Qualifications :

The base pay for this position is $112,000.00 $224,000.00. In specific locations, the pay range may vary from the range posted.