Alfasigma USA seeks a Regulatory Affairs Director to lead the regulatory and compliance efforts. The Regulatory Affairs Director will be housed in our Bedminster, NJ. office and will directly report to the Chief Integration Officer.  This person will be responsible for designing and implementing a viable regulatory strategy that provides a speedy and optimal access of new products to the market while ensuring that the regulatory status of Alfasigma USA (ALUSA) products is fully compliant and updated in accordance with applicable US regulations and Alfasigma Group internal policies.   Masters the different regulatory environments as required and engages with government bodies, external consultants, and industry associations to discuss and protect ALUSA interests.

ESSENTIAL FUNCTIONS:

• Designs and implements regulatory strategies to grant a speedy and optimal access of new products (Medical Foods, Medical Devices and Prescription drugs) to the market.
• Ensures full compliance with Regulatory and Pharmacovigilance legislation and guidelines.
• Engages with government bodies, external consultants, and functional industry associations.
• Supports the Manufacturing Quality and Technical Groups.

REQUIREMENTS:

• Bachelor’s degree required, PhD preferred. Degree in Life Sciences, Pharmacy or Chemistry preferred
• 5+ years Regulatory Affairs experience in the pharmaceutical industry required
• High exposure to and involvement with industry groups, government authorities (FDA), and scientific societies

 KEY SUCCESS FACTORS:

• Entreprenurial spirit
• Enjoys working autonomously
• Self starter
• Works well under littler supervision
• Takes the initiative

The ideal candidate with a PhD or a Life Sciences degree has acquired a sound knowledge of Pharma Regulatory Affairs in a first or second management line of a Pharma multinational company. A Senior Director or Department Head experience are desirable but are not considered as a must.

The successful candidate will be someone that thrives in a small organization with a wide scope of responsibilities and with the ability to roll up their sleeves and get the work done.

Able to communicate with internal departments (Marketing, Medical, Legal), external bodies, consultants and Corporate functions in European HQ.

Alfasigma USA, Inc. is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee on the basis of race, color, religion, creed, national origin or ancestry, sex, age, physical or mental disability, veteran status, genetic information or any other legally recognized protected basis under federal, state or local laws, regulations or ordinances. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on Alfasigma USA, Inc. Please inform the HR Assistant if you need assistance completing any forms or to otherwise participate in the application process.