Regulatory Affairs Professional (CMC)

Job Introduction

Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra.

Dechra are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.

Here at Dechra, our values are embedded within our culture and thrive within our family of over 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business.

The Opportunity

Dechra is an international veterinary pharmaceuticals and specialty healthcare products business. Our expertise is in the development, manufacture, and sales and marketing of high-quality products exclusively for veterinarians worldwide. The primary purpose of the Regulatory Affairs Professional will be to support the delivery of assigned product / project goals and to support the company’s strategic goals and technical excellence. This role will be dedicated to Dechra’s MedPharmex manufacturing site in Pomona, CA and will report to the site’s Regulatory Affairs Manager. This role will aim to support the company’s Consent Decree Remediation activities and improvement initiatives, as well as other regulatory activities required to maintain regulatory compliance for existing MedPharmex products.

Role Responsibility

So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including:

Providing regulatory expertise and support for the regulatory remediation strategy, process, filing, best practices, etc. for all products manufactured at MedPharmex, with specific attention to CMC (Chemistry, Manufacturing, and Controls) for currently approved NADA and ANADA products.
Support the execution of regulatory strategies to support responses to agency questions relating to CMC, dossier remediation activities and lifecycle management of existing products manufactured at MedPharmex.
Partner effectively with QA and Manufacturing Science and Technology to deliver on site goals.
Assist in authoring regulatory content for submissions related to assigned projects/products.
Maintain knowledge of changing regulatory requirements and advise teams as appropriate (Regulatory Intelligence).
Provide strategic, expedient and efficient preparation of assigned deliverables that meet current regulatory and technical requirements.
Evaluate change controls for impact and filing requirements.
Build, develop, and maintain working relationships with internal and external stakeholders.
Participate in ongoing process improvement activities within Regulatory Affairs and cross-functionally.
Develop procedures to ensure regulatory compliance and review company practices.
Maintenance of regulatory filings and information.
Support other post-approval compliance regulatory activities as needed.
Travel may be required (<10%).

The Ideal Candidate

Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We’re particularly excited to hear from those who have/are:

Minimum 3 years’ experience in CMC Regulatory Affairs (preferably within the Animal Health industry)
University degree in chemistry, biochemistry, pharmacology, or other relevant life science
Strong understanding of GMP requirements, specifically pertaining to chemistry, manufacturing, and controls (CMC).
Exceptional attention to detail.
Effective listening, verbal, and written communication.
Good interpersonal skills, with the ability to communicate effectively with all levels, establishing and maintaining effective working relationships.
Able to plan, organize and prioritize multiple priorities and issues to meet deadlines.
Able to keep several projects moving forward at the same time.
Ability to be flexible due to frequent shifts in priorities.

Desirable:

Knowledge of the CTD format
Familiarity with veterinary pharmaceutical regulations and industry
Creative problem solving approach
Proficient computer skills
Broad knowledge of post-approval regulatory maintenance activities

About the Company

As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and an employee stock purchase plan for long-term financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.