Regulatory Affairs Head At Abbott Laboratories
PRIMARY JOB FUNCTION:
Combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation.
Develop and supervise regulatory professionals.
Department level influencer and is generally considered as an expert resource both within Abbott and externally.
Influence changing regulations and guidance, interface with outside regulatory agencies and trade associations.
Plan, direct, coordinate and control the regulatory affairs activities related to products within the area of responsibility.
Scientific office responsibilities.
CORE JOB RESPONSIBILITIES:
Evaluate regulatory risks of corporate policies.
Provide strategic guidance for product development and planning throughout the product lifecycle.
Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
Develop global regulatory strategies and update based upon regulatory changes.
Conduct regulatory due diligence for potential and new acquisitions and advise management.
Utilize technical regulatory skills to propose strategies on complex issues.
Monitor trade association position for impact on company products.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
Recruit, develop and manage regulatory professionals.
Provide guidance for resource and development planning.
Participate in applicable trade association/industry working groups to influence policy/rulemaking in alignment with business strategies.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Approve regulatory filing strategies based upon proposed preclinical, clinical and manufacturing changes.
Monitor impact of changing regulations on submission strategies.
Negotiate with regulatory authorities during the development and review process to ensure submission approval.
Formulate company procedures to respond to regulatory authority queries.
Maintain importation plan for EG affiliate and align with cross functionally on any possible risks .
Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
Ensure compliance with product post marketing approval requirements.
Review and approve advertising and promotional items to ensure regulatory compliance.
Ensure external communications meet with regulations.
Identify and present option for risk mitigation to decision makers.
Represent regulatory affairs in product recall and recall communication process.
Planning / Organization:
Creates immediate, mid & long-range regulatory plans to carry out objectives.
Develops and calculates a budget for regulatory department to meet organizational goals.
Determines and establishes organizational structure and supervisory relationships subject to top management approval.
Maintain up to date DARIUS records and Isotrain.
Direct Reports: 2 direct reports.
EXPERIENCE/ EDUCATION REQUIRED:
University degree preferably in Pharmaceutical Sciences with 10 years’ experience in regulatory affairs.
At least 4 years of managerial position in multinational pharmaceutical companies.
Able to work in a cross-functional environment with strong management skills.
Need to be confident in communicating in English.
Good knowledge of Manufacturing Practices, Pharmacovigilance and current legislation governing product registration.