Senior Regulatory Affairs Specialist Nutrition

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader creating breakthrough science to improve peoples health. Were always looking towards the future anticipating changes in medical science and technology.

Our nutrition business develops science-based nutrition products for people of all ages from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands including Similac PediaSure Pedialyte Ensure Glucerna and ZonePerfect to help get the nutrients they need to live their healthiest life.

Please note any offer of employment for this position is conditional upon the successful completion of a pre-employment medical examination including drug and alcohol screening conducted by a medical practitioner designated by the Company.

Applicants across Europe can apply. This is an on-site based position.

Working at Abbott

At Abbott you can do work that matters grow and learn care for yourself and family be your true self and live a full life. Youll also have access to:

• Training and career development with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation incentives and retirement plans
• Health care and well-being programs including medical dental vision well

IN RESPONSIBILITIES

Major Responsibilities:

• Ensures timely approval of Nutritional products functional foods & drugs for EURI region. Possess well developed skills in directing development of product registration dossiers submission progress reports deficiencies amendments etc.
• Provide regulatory input to product lifecycle planning.
• Lead regulatory submissions strategy and update strategy based upon regulatory changes.
• Interpret and apply regulatory requirements.
• Understand investigate and evaluate regulatory history/background of product context in order to assess regulatory implications for approval.
• Understand the business environment and relate extensive knowledge of internal and external activities to trends; determine trade issues to anticipate regulatory obstacles.
• Participate in risk-benefit analysis for regulatory compliance.
• Plan and organize project assignments of substantial variety and complexity; initiate and/or maintain schedule for projects and project milestones.
• Maintain regulatory data in electronic systems.
• Depending on specific role the Regulatory Affairs Specialist may be involved in various regulatory activities (review of product documentation; regulatory submissions and follow-up; evaluation of product and manufacturing changes for regulatory implications; maintaining annual licenses registrations listings and patent information; review and approval of label changes advertising and promotional items; provide regulatory input to product safety issues and product recalls etc.)
• Partners with affiliates to support regulatory agency interactions to expedite approval of pending registration.
• Participates/ Awareness on Affiliates Business plans project plan regulatory submission strategy any risks management.
• Advises project teams on manufacturing changes line extensions technical labeling appropriate regulations and interpretations.
• Partner with other regulatory functions for smooth project transition and launch.
• Submit and review change controls to determine the level of change and consequent submission requirements.
• Assist in SOP development and review.

Supervisory/Management Responsibilities (Influence/Impact/Leadership):

• May provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees.
• Participate in the development of less experienced staff by setting an example providing guidance and offering counsel.
• Influence middle management on technical or business solutions.
• Perform work under minimal supervision and may independently determine and develop approach to solutions.

EDUCATION AND EXPERIENCE YOULL BRING

Required:

• Bachelors degree (or equivalent) is required - preferred area of focus in science (biology chemistry nutrition dietetics microbiology immunology medical technology pharmacy and pharmacology) math engineering or medical fields. M.S. in a technical area is preferred. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Skills/Experience Requirements:

• 2-3 years of experience in regulatory preferred but may consider quality assurance research and development scientific affairs operations or related area.
• 3-4 years of experience in a regulated industry (e.g. nutritionals medical products).
• Regulatory knowledge of (as applicable - note: This knowledge may be developed through tenure in this position.):
  • a. Regulatory requirements guidelines policies standards practices history ethics agency structure and processes etc.
  • b. GxPs (GMPs GLPs GCPs).
  • c. Principles and requirements of promotion advertising and labeling.
  • Experience/ keen desire to utilize RIMS (systems) for submission dossiers management
  • Experience in stakeholder management specifically with manufacturing sites.

• Communication skills and ability to:

• a. Communicate effectively verbally and in writing.
  • b. Communicate with diverse audiences and personnel.
  • c. Work with and negotiate with people from various disciplines organizations and cultures.
  • d. Follow scientific arguments identify regulatory scientific data needs and with supervision solve regulatory issues and define regulatory strategy.
  • e. Evaluate various technical alternatives.

• Other skills:

• a. Strong attention to detail.
  • b. Create and manage project plans and timelines.
  • c. Think analytically; organize and track complex information.
  • d. Proficient computer skills.

Accountability/Scope:

• Execute and manage technical and scientific regulatory activities.
• Participates in conflict resolution at the team level.
• Function independently as a decision-maker on regulatory issues and assure that deadlines are met.
• May lead a cross-functional project team.

The base pay for this position is

In specific locations the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: