Regulatory Affairs Specialist At Abbott
Primary Function/Primary Goals/Objectives:
Provide support for the regulatory department to ensure efficient and compliant business processes and environment.
Execute regulatory tasks and exercise influence generally at the middle management level.
Maintain current registrations by preparing documentation required and submitting documentation on schedule as directed.
Ensures timely approval of Nutritional products, functional foods & drugs for MENAP & EURI regions. 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.
Bachelor's 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.)
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.
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.
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.
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.