1+ months
2018-03-152018-07-20

Sr. Specialist Regulatory Affairs

Abbott
Alameda, CA

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Position Summary

As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.  The individual may execute tasks and play a consultative role by partnering across business functions.  The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide.  The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

Main Responsibilities

As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment.

The individual may execute tasks and play a consultative role by partnering across business functions.

The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide.

The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

Assist in SOP development and review 

Provide regulatory input to product lifecycle planning.

Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.

Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.

Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.

Determine trade issues to anticipate regulatory obstacles.

Determine and communicate submission and approval requirements.

Participate in risk benefit analysis for regulatory compliance.

Assess the acceptability of quality, preclinical and clinical documentation for submission filing.

Compile, prepare, review and submit regulatory submission to authorities.

Monitor impact of changing regulations on submission strategies.

Monitor applications under regulatory review.

Monitor and submit applicable reports to regulatory authorities.

Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.

Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.

Maintain annual licenses, registrations, listings and patent information.

Assist compliance with product post marketing approval requirements.

Review and approve advertising and promotional items to ensure regulatory compliance.

Assess external communications relative to regulations.

Review regulatory aspects of contracts.

Assist with label development and review for compliance before release.

Submit and review change controls to determine the level of change and consequent submission requirements.

Analyze the input of cumulative product changes to current product submissions.

Contribute to the development and functioning of the crisis/ issue management program.

Ensure product safety issues and product associated events are reported to regulatory agencies.

Provide regulatory input for product recalls and recall communications.

Accountability

Individuals execute and manage technical and scientific regulatory activities.

Must function independently as a decisionmaker on regulatory issues, and must assure that deadlines are met.

Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies.

Properly interpret and apply regulatory requirements.

Work is performed without appreciable direction and exercises some latitude in determining technical objectives of assignments.

Work is reviewed upon completion for adequacy in meeting objectives.

Individual is recognized as an expert in work group.

Understands business environment and relates extensive knowledge of internal and external activities to trends.

Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.

Participates in the development of others by facilitating training and providing feedback and guidance.

May lead a cross functional project team.

Provides technical leadership to business units.

Acts as a mentor to less experienced staff.

Exercises judgment independently.

Plans and organizes project assignments of substantial variety and complexity.

Initiates or maintains schedule for projects and project milestones.

Establishes priorities of individual or project assignments.

Selects methods and techniques to lead a project to completion.

Erroneous decisions or recommendations would typically result in failure to achieve organizational objective.

Comments (Optional):

Individual may provide direction and guidance to exempt and/or skilled non-exempt levels of employees.

Also may be asked to evaluate performance of and assist in career development planning.

Qualifications

Bachelors degree (or equivalent); Bachelors degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. 

Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)  

2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 3-4 year’s experience in a regulated industry (e.g., medical products, nutritionals). Note: Higher education may compensate for years of experience. 

Regulatory history, guidelines, policies, standards, practices, requirements and precedents  Regulatory agency structure, processes and key personnel  Principles and requirements of applicable product laws  Submission/registration types and requirements  GxPs (GCPs, GLPs, GMPs)  Principles and requirements of promotion, advertising and labeling  International treaties and regional, national, local and territorial trade requirements, agreements and considerations  Domestic and international regulatory guidelines, policies and regulations  Ethical guidelines of the regulatory profession, clinical research and regulatory process  Regulatory history, guidelines, policies, standards, practices, requirements and precedents 

Regulatory agency structure, processes and key personnel 

Principles and requirements of applicable product laws 

Submission/registration types and requirements  GxPs (GCPs, GLPs, GMPs)  Principles and requirements of promotion, advertising and labeling 

International treaties and regional, national, local and territorial trade requirements, agreements and considerations 

Domestic and international regulatory guidelines, policies and regulations  Ethical guidelines of the regulatory profession, clinical research and regulatory process  Pay strong attention to detail 

Manage projects 
Create project plans and timelines 

Think analytically 

Organize and track complex information 

Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results 

Has broad knowledge of various technical alternatives and their potential impact on the business

 Exercise good and ethical judgment within policy and regulations 

Use in-depth knowledge of business functions and cross group dependencies/ relationships 

Define regulatory strategy with supervision 

Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues
Job Family: Regulatory Operations
Division: ADC Diabetes Care
Travel: Yes, 5 % of the Time
Medical Surveillance: Yes
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Sr. Specialist Regulatory Affairs

Abbott
Alameda, CA

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Sr. Specialist Regulatory Affairs

Abbott
Alameda, CA
US

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