Senior Regulatory Affairs Specialist

Abbott • Santa Clara, CA

1d • $90,000 - $180,000 • Onsite

About The Position

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.

Requirements

• Bachelors Degree (± 16 years) Related field OR an equivalent combination of education and work experience
• Minimum 3 years 3-4 years experience in a regulated industry (e.g., medical products, nutritionals).
• 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Knowledge of: Regulatory history, guidelines, policies, standards, practices, requirements and precedents.
• Knowledge of: Regulatory agency structure and processes.
• Knowledge of: Principles and requirements of applicable regulations and agency guidance.
• Knowledge of: Submission/registration types and requirements.
• Knowledge of: GxPs (GCPs, GLPs, GMPs).
• Knowledge of: Principles and requirements of promotion, advertising and labeling.
• Knowledge of: Ethical guidelines of the regulatory profession.
• Communication Skills or Ability to: Communicate effectively verbally and in writing.
• Communication Skills or Ability to: Communicate with diverse audiences and personnel.
• Communication Skills or Ability to: Write and edit technical documents.
• Communication Skills or Ability to: Work with cross-functional teams.
• Communication Skills or Ability to: Work with people from various disciplines and cultures.
• Communication Skills or Ability to: Negotiate internally and externally with regulatory agencies.
• Cognitive Skills or Ability to: Pay strong attention to detail.
• Cognitive Skills or Ability to: Manage projects.
• Cognitive Skills or Ability to: Create and maintain project plans and timelines.
• Cognitive Skills or Ability to: Think analytically.
• Cognitive Skills or Ability to: Organize and track complex information.
• Cognitive Skills or Ability to: Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Cognitive Skills or Ability to: Has broad knowledge of various technical alternatives and their potential impact on the business.
• Cognitive Skills or Ability to: Exercise good and ethical judgment within policy and regulations.
• Cognitive Skills or Ability to: Use in-depth knowledge of business functions and cross group dependencies/relationships.
• Cognitive Skills or Ability to: Define regulatory strategy with supervision.
• Cognitive Skills or Ability to: Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues.

Nice To Haves

• Masters Degree (± 18 years) In Regulatory Affairs preferred and may be used in lieu of direct regulatory experience.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Responsibilities

• Assist in SOP development and review.
• Provide regulatory input to product lifecycle planning.
• 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 of 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.
• Manage and oversee the preparation of high-quality global filings for sustaining changes and new product registration.
• Manage rest of world (all geographies outside the US and EU) submissions.
• Serve as a regulatory team member on product development and sustaining teams, providing clear, concise regulatory strategy to ensure applicable global requirements are met for product development and quality system products.
• Assist company SMEs to interpret existing or new regulatory requirements for company products and procedures, labeling, marketing projects, testing and record keeping.
• Anticipate and advise on future regulatory trends and direction and recommend preemptive approaches for company regulatory.
• Proactively track global regulatory requirement changes and work with Global Strategic Intelligence (GSI) team to disseminate the information to all team members.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree

What This Job Offers

• Job Type: Full-time
• Career Level: Senior