Job Description

JOB DESCRIPTION:

Abbott is a global healthcare leader, creating breakthrough science to improve people\xe2\x80\x99s health. We\xe2\x80\x99re 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 \xe2\x80\x93 including Similac\xc2\xae, PediaSure\xc2\xae, Pedialyte\xc2\xae, Ensure\xc2\xae, Glucerna\xc2\xae and ZonePerfect\xc2\xae \xe2\x80\x93 to help get the nutrients they need to live their healthiest life.

Primary Function:

• Provide support for the regulatory department to ensure efficient and compliant business processes and environment.
• Execute regulatory tasks and play a consultative role by partnering across business functions
• Assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide
• Prepare and submit documentation or oversee preparation of documentation needed for registration worldwide
• Provide technical leadership to business units

Major Responsibilities:

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures and Regulatory SOPs
• Assist in Regulatory SOP development and review
• Provide regulatory input to product lifecycle planning
• Assist in the development of regulatory strategy and update strategy based upon regulatory changes
• Interpret and apply regulatory requirements
• Understand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic 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 Sr Regulatory Affairs Specialist may be involved in various regulatory activities (review of clinical 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.)
• May provide direction and guidance to exempt and/or skilled non-exempt levels of employees; act as a mentor to less-experienced staff. May be asked to evaluate performance of others and to assist in career development planning. Participate in the development of others by facilitating training and providing feedback and guidance. Interface with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units. Perform work without appreciable direction

Requirements:

• Bachelor\'s Degree in Science/Pharmacy or related Engineering/Medical fields
• Min 6-8 years of experience with at least 2-3 years of experience in a Regulatory Affairs role within regulated industry (e.g. nutritionals/pharmaceuticals).
• Candidates with prior experience in Nutritional/Pharmaceutical/Medical Device industry preferred.
• RA Professional Certification is an added advantage
• Strong regulatory knowledge in areas pertaining to regulatory requirements, guidelines, policies, standards, practices, history, ethics, agency structure and processes, etc; GxPs (GMPs, GLPs, GCPs); Principles and requirements of promotion, advertising and labeling
• Good communication skills, effective verbal and writing skills and able to communicate with diverse audiences and personnel
• Able to work with and negotiate with people from various disciplines, organizations, and cultures
• Able to follow scientific arguments, identify regulatory scientific data needs and, with supervision, solve regulatory issues and define regulatory strategy
• Able to evaluate various technical alternatives
• Strong attention to detail
• Create and manage project plans and timelines
• Think analytically; organize and track complex information
• Proficient computer skills

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

The salary for this role is between: N/A

JOB FAMILY: Regulatory Operations

DIVISION: AN Abbott Nutrition

LOCATION: Singapore
Singapore : DUO Tower

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Not specified

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott