CMC Assistant, Regulatory Affairs, US

Alpharma Inc. is a global specialty pharmaceutical company with leadership positions in products for humans and animals. Uniquely positioned to expand internationally, Alpharma is presently active in more than 60 countries. Among the world’s leading producers of several important pharmaceutical-grade bulk antibiotics, Alpharma has a growing pharmaceutical business and is internationally recognized as a leading provider of pharmaceutical products for poultry, swine and cattle.

 

Currently the Animal Health Division of Alpharma is looking for a CMC Assistant to support the US Regulatory Affairs.  This position will be based out of our Headquarters in Bridgewater, NJ.

 

SUMMARY: Responsible for filing for new approvals and maintaining the exiting ones for the CMC sections (manufacturing facilities and testing laboratories) of Alpharma’s US registrations.  Coordinate all regulatory aspects of obtaining and maintaining CMC section approval to manufacture Alpharma Animal Health products in the US.  Establish and maintain contacts with industry groups, and  regulatory authorities especially the FDA and scientific committees.

 

ESSENTIAL DUTIES and RESPONSIBILITIES include the following.  Other duties may be assigned.

 

·  Utilize project management skills to monitor progress of submissions through the evaluation process and produce regulatory status reports on progress.

·  Liaise with other departments (Production, Quality Control, Quality Assurance, Purchasing, Logistics, etc.) to obtain and maintain regulatory approval of CMC sections for products.

·  Coordinate production of manufacturing sections, product information, documents, etc. to support submissions for products made in US approved manufacturing sites.

·  Provide interface with various regulators, contract manufacturers, regulatory consultants, contract laboratories, etc.

·  Develop working knowledge of US regulations and legislation and inform management of changes that may affect Alpharma products and development projects.

·  Assist in the preparation of manufacturing section of submissions for new registrations, re-registrations, etc.

·  Support the Global Regulatory Affairs and Compliance sections.

·  Maintain awareness of what is happening in the Animal Health Industry including competitors’ activities

 

QUALIFICATIONS:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Willing to travel (approximately 10%)

 

EDUCATION and EXPERIENCE: Minimum BS/MS in chemistry or pharmaceutical sciences degree from an accredited college or university and 1-2 years experience in animal health or human pharmaceutical CMC regulatory affairs or equivalent experience.

 

LANGUAGE SKILLS: Ability to read, analyze and interpret documents such as professional journals, technical procedures and government regulations in English.  Ability to write regulatory submissions, technical procedures and business correspondence. Ability to effectively communicate with other departments, regulatory agencies and other members of the animal health industry.  Fluency in English is required.

 

MATHMATICAL SKILLS: Ability to work with mathematical concepts such as probability and statistical inference.  Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.  Ability to present research data in reports and submissions.

 

OTHER QUALIFICATIONS: Ability to work cooperatively with other departments and individuals.  Ability to efficiently use current versions of the Microsoft® Office® Suite (Access®, Excel®, PowerPoint® and Word®), Microsoft Project, Lotus Notes and similar computer software.