RegCMC Strategist

POSITION RESPONSIBILITIES:

The successful candidate will support all regulatory CMC aspects of an assigned product portfolio veterinary drug development projects regulatory change management and/or routine registration maintenance.  Develop regulatory CMC filing strategies for global pharmaceutical dosage forms.  Support CMC activities for new product development teams and postapproval manufacturing changes or site transfers.  Prepare responses to global Health Authority queries including FDA/CVM.  Maintain knowledge and awareness of emerging global biopharma and pharmaceutical CMC regulations.

 Provide regulatory support and serve as a technical liaison on Development teams in their efforts to deliver a quality CMC technical section that will meet global requirements for registration approval and launch of a new product.    Develop a knowledge of CMC regulatory science.  Work with VMRD Pharmaceutical Sciences to ensure appropriate alignment and sharing of best practices.

Other:

Previous experience with microbiological techniques biopharmaceutical manufacturing analytical methods aseptic processing and Animal Health products is highly desirable.

Position may require some travel less than 10%.

Qualifications :

EDUCATION AND EXPERIENCE:

Minimum of a Bachelor degree with 3 years of analytical manufacturing and regulatory experience with biologics biopharmaceutical or pharmaceutical products. 

Strong technical background and excellent communications skills required with regulatory experience highly preferred. 

Candidates with experience in a regulatory liaison role working directly with FDA (CVM) or other global Health Authorities in the area of biological biopharmaceutical or pharmaceutical registration and compliance is highly desirable.

Experience in using problemsolving skills to propose and evaluate regulatory solutions to CMC issues and manage the preparation of contingency plans to meet the objectives of the Business in a highly competitive market.  Must be able to apply high level informatics and document management skills within a matrix cross divisional environment.  Must demonstrate integrity in all areas of the work environment; assess business and scientific ethics for all regulatory decisions and strategic plans.

Other Attributes Desirable:

*Experience in genetic engineering bioprocessing protein analysis microbiology and development activities for products in support of the preparation and submission of regulatory CMC dossiers to meet global business objectives and Health Authority requirements.

* Understanding of GMPs for sterile and nonsterile manufacturing

* Understanding of global standards for analytical testing

* Very selfdirected can work with little supervision on most tasks

* Excellent organization prioritization and time management skills can work effectively under pressure

* Excellent written and oral communication skills

* Experience with an animal health portfolio

* Manage and adapt to change

Additional Information :

What we offer:

• Excellent full time benefits including comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins Lancaster Laboratories Professional Scientific Services (PSS) is a global awardwinning insourcing solution that places our people at our clients site dedicated to running and managing laboratory services while eliminating headcount coemployment and projectmanagement worries.

We infuse our 55year track record of scientific and laboratory operations expertise as well as HR and great place to work best practices to recruit hire train and manage highly qualified scientists to perform laboratory services using our clients quality systems and equipment.

Eurofins USA PSS Insourcing Solutions is a M/F Disabled and Veteran Equal Employment Opportunity and Affirmative Action employer.

Remote Work :

No

Employment Type :

Fulltime