Senior Manager, Regulatory Affairs

Senior Manager of Regulatory Affairs

The Senior Manager of Regulatory Affairs plays a crucial role in ensuring Proliant Health & Biologicals (PHB) products comply with local and international regulations within our three key markets – diagnostics, therapeutics, and nutrition. This role involves working closely with regulatory agencies, cross-functional teams, and stakeholders to develop and implement regulatory strategies.

Job Qualifications

The ideal candidate will have prior experience in pharmaceuticals, human nutrition, medical device, or diagnostic industries as well as experience working with major regulatory and government agencies including USDA, APHIS, and FDA and possesses strong people development and decision-making skills.

Education:

• Bachelor’s degree required in relevant discipline.
• Master’s degree preferably in human nutrition, biochemistry, or comparable discipline strongly preferred.

Experience:

• Minimum of 6 years’ regulatory experience in food, pharmaceutical industry, or medical device industry of increasing responsibility required.
• Experience with CMC and CDER requirements preferred.
• Background in the quality discipline is a plus.

Skills

• Professional conduct with high attention to detail.
• Strong verbal and written communication skills.
• Ability to work collaboratively and coordinate with team members.
• Competence in multitasking and organizational methods.
• Self-starter, strategic thinker with demonstrated strong analytical skills with proven ability to follow logical progression of thought.
• Proficient in MS Office, eQMS such as (Reliance) or similar, MS Teams.
• Interpret and communicate complex government rules & regulations.
• Excellent verbal and interpersonal communication skills; ability to present ideas effectively to all levels of management.
• Excellent organizational and time management skills, demonstrated prioritizing, planning, and project management skills.
• Willingness to travel internationally and domestically as required.
• Extended work hours as necessary.

Key Responsibilities

Strategic Liaison:

• Serve as the primary liaison for PHB Regulatory Affairs, aligning strategies with Quality Assurance, Corporate, Sales, and Operations.

Regulatory Leadership:

• Develop and lead regulatory strategies and ensure alignment with overarching PHB business strategies.
• Provide regulatory leadership with expertise in CMC and CDER requirements.
• Manage interactions with health authorities, including meetings and communications.

Submission Management:

• Develop and manage systems for high-quality submissions to regulatory health authorities.
• Coordinate regulatory document collection and inspection and audit needs for product and facility registrations.

Monitoring and Communication:

• Monitor changes in the regulatory environment and communicate their impact internally.
• Support international market access for US and New Zealand products.

Compliance and Quality Systems:

• Maintain Quality Systems knowledge to support Regulatory Affairs and Quality Assurance for compliance and continuous improvement.
• Handle import/export permits and renewals, supporting Customer Service and Sales with related issues.

Collaboration and Coordination:

• Collaborate with various regulatory bodies such as USDA/APHIS, FDA, EMA, CFIA.
• Collaborate with LGI regulatory affairs for best practice implementation.

Stakeholder Engagement:

• Influence and educate stakeholders on regulatory policy decisions.
• Lead cross-functional teams for problem-solving and project execution.

Documentation and Training:

• Organize and electronically file documents supporting regulatory submissions and facility registrations/renewals per QMS and document management policies.
• Keep updated with regulatory developments through webinars, classes, and workshops.
• All other duties as assigned.

Learn more here