PHD Regulatory Affairs Lead

Location: United States (with International Travel as Required)
Division: Corporate – Pharma, Health, and Durables (PHD)
Reports to: Group Director Sustainability Operations & Regulatory Affairs

About Us:
Klockner Pentaplast (kp) is a global leader in sustainable packaging solutions, dedicated to providing innovative products that meet stringent regulatory standards. We are committed to excellence and are looking for a skilled PHD Regulatory Affairs Lead to guide our regulatory compliance agenda within the PHD Division.

Key Responsibilities:
 

• Lead the execution of the PHD division's regulatory affairs agenda, ensuring alignment with business objectives and global standards.
• Monitor and interpret regulatory requirements (e.g., CFR 21, cGMP, EU) to ensure kp products and sites are compliant, managing re-certification processes as needed.
• Serve as the primary contact for the PHD division, working closely with the legal team on regulatory issues and providing solutions to mitigate risks.
• Conduct regulatory assessments on product and process changes, developing relationships with regulatory authorities and stakeholders.
• Collaborate across departments (Legal, Procurement, Quality, Innovation, Commercial) to integrate regulatory considerations into product development processes.
• Engage with external regulatory bodies and customers, representing kp and influencing the global regulatory environment.

Management and Strategy:

• Oversee the implementation of regulatory affairs across all manufacturing plants in the PHD division.
• Act as a senior regulatory affairs champion within kp, addressing escalated matters and publicly advocating for the division's regulatory approach.
• Promote proactive product stewardship to support current and future product offerings.

Skills and Qualifications:

• Degree in Science, Engineering, or a related field.
• A number of years experience in regulatory affairs, particularly within the Medical Device, Pharma, or Durables industries.
• In-depth knowledge of regulatory standards (cGMP, ISO 13485, FDA, EU) and the packaging industry, with the ability to communicate effectively with diverse audiences.
• Strong analytical skills, project management expertise, and a proactive communication style.
• Proven ability to work under pressure and meet deadlines while fostering collaborative relationships.

What We Offer:
 

• A vital role in a global organization focused on sustainability and innovation.
• Opportunities for professional growth and the chance to lead regulatory strategy within the PHD Division.
• A collaborative work environment where your contributions will make a significant impact on product development and compliance.   #LI-REMOTE

Apply Now!

If you are determined, thrive in a fast-paced environment with high levels of accountability and focus, then we’d love to meet you! Please apply using the link below.

At kp, Diversity, Equity and Inclusion is vital to our global success. We welcome applicants from all identities, ideas, perspectives and experiences and encourage people from underrepresented backgrounds to apply. We aim to create an inclusive culture where our employees feel empowered to play to their strengths and see themselves reflected in the organization without regard to race, gender, religion, national origin, age, veteran status, disability, sexual preference, marital status, or inclusion in any other protected class.