Sr. Regulatory Affairs Specialist

Responsibilities: Essential Duties

• Plans and prepares registration documents for marketing approval of drug and device products in the US and in foreign countries.
• Serves as a regulatory liaison for new product development and make regulatory assessments of proposed changes to existing products for impact to regulatory documentation.
• Provides strategic input and guidance to project teams in conjunction with supervisor.
• Plans and prepares dossiers for registration of drug and device products.
• Independently reviews and analyzes proposed modifications to drug and device products for regulatory impact.
• Independently reads, reviews, interprets and keeps current with regulations and publications regarding drug and device products and communicate within the department.
• May oversee and direct the work of other Regulatory Affairs professionals.

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

Expertise: Knowledge & Skills

• Requires full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.
• Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, assigning and checking the work of lower level employees. Referring only complex problems and issues
• Judgement is required in resolving complex problems based on experience.
• Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors.