🌎
This job posting isn't available in all website languages

Sr Regulatory Affairs Analyst

📁
Research & Development
📅
183681 Requisition #
Thanks for your interest in the Sr Regulatory Affairs Analyst position. Unfortunately this position has been closed but you can search our 420 open jobs by clicking here.

 

Requirements:

 

Submissions:  Plans and prepares complex regulatory documents for US and potentially OUS submissions, under minimal supervision.  Resolves submission problem areas with input from supervisor.  Prepares clear and accurate internal and external complex administrative and scientific documents, under minimal supervision.  Review of labeling and packaging components to ensure accuracy and compliance with government regulations

 

Advisory Responsibilities:  Participates on global regulatory teams.  Works with team to resolve complex project issues.  Has recognized regulatory expertise and extensive knowledge of regulatory requirements and regulations with ability to strategically interpret and communicate requirements.

 

Communications:  Maintains professional relationships with functional areas outside regulatory.  Develops professional relationships with Health Authorities through supervised process.  Interacts as appropriate with outside vendors, suppliers, contract research organizations, and others.  Prepares documentation that is complete, accurate, and on time. Is responsible for distribution and filing.

 

Regulatory Compliance:  Critically reviews complex reports, validations, etc. for scientific merit and regulatory appropriateness under limited supervision.  Approves manufacturing process changes in consultation with supervisor, as appropriate.  Interprets compliance regulations within the scope of departmental policy.

 

Supervisory Responsibilities:  Performs peer review of complex regulatory documents.  With input from supervisor, identifies and recommends solutions for problems identified.  Assists in limited aspects of training for personnel and may supervise as appropriate.

 

Essential Skills and Abilities

 

  • Excellent interpersonal skills and supervisory potential.
  • Computer literate with excellent knowledge of Allergan systems for electronic storage and submission
  • In-depth knowledge of regulations
  • Good negotiation skills.

 

Education

 

Education equivalent to a BS degree in a scientific field, plus six years’ experience in regulatory affairs;  or

 

Education equivalent to a MS degree in a scientific field, plus four years’ experience in regulatory affairs;  or

 

Education equivalent to a PhD degree in a scientific field, plus two years’ experience in regulatory affairs.

 

At least two years of medical device experience strongly desired.

Equal Employment Opportunity Employer


Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.

Previous Job Searches

My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Applications

Track your opportunities.

My Applications