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Sr. Regulatory CMC Scientific Leader Opportunity (Overland Park, KS or Portland, ME)

Job Introduction

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

Dechra is 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 almost 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

The primary purpose of the Sr. Regulatory Affairs Scientific Leader will be to deliver assigned product / project goals and to support the company’s strategic goals and technical excellence.

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:

  • Act as a key Regulatory Affairs consultant, providing expertise and innovative solutions to internal development or lifecycle teams on regulatory strategy, process, filing, best practices, etc. for a broad range of product types and indications with specific attention to CMC (Chemistry, Manufacturing, and Controls).
  • Drive execution of regulatory strategy to support lifecycle management of existing products.
  • Drive regulatory strategy for assigned new products to optimize time to approval in collaboration and alignment with the product development team.
  • Author regulatory content for submissions related to assigned projects/products.
  • Review and oversight of submission content through product development or technology transfer teams.
  • 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.
  • Liaise with regulatory authorities on assigned projects under direction of Sr. US RA Management.
  • Build, develop, and maintain working relationships with internal and external stakeholders.
  • Participate in ongoing process improvement activities within Regulatory Affairs and cross-functionally.
  • Mentor and train junior staff as assigned.
  • Assure that management are kept informed of key issues, obstacles and achievements in a timely manner.
  • Travel may be required (<10%).

Key Performance Indicators

  • Accomplish prioritized submissions for development and maintenance projects for US and global markets as assigned.
  • Maintain existing regulatory tools.
  • Promote organizational values and organizational culture through one's own behavior and encouraging others' desired behaviors.

The Ideal Candidate

Competencies:

Deciding and Initiating Action

Engagement

Applying Expertise and Technology

Problem Solving

Relationship Management

Leading, Coaching and Supervising

Analyzing and Interpreting

Delivering Results and Meeting Customers' Expectations

Skills - Essential:

  • Strong understanding of GMP requirements, specifically pertaining to chemistry, manufacturing, and controls (CMC).
  • Exceptional attention to detail.
  • Effective listening, verbal, and written communication.
  • Excellent 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
  • Strategic thinking and creative problem solving

Skills - Desirable:

  • Familiarity with veterinary pharmaceutical regulations and industry.
  • Knowledge of the CTD format

Knowledge and Experience - Essential:

  • At least 5 years US regulatory affairs CMC focused experience.

Knowledge and Experience - Desirable:

  • Experience with EU, UK or other global Regulatory Affairs submissions
  • Additional background in manufacturing, technology transfer, quality, or analytical laboratory environment

Qualifications:

  • Bachelor of Science in chemistry, veterinary medicine, chemical engineering, biochemistry, or other related life science

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.

Dechra Pharmaceuticals PLC

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