Manager Regulatory Affairs

Job Description

Lead Quality and Regulatory Services Initiatives: Manage aspects of combination product programs and projects, coordinating with both internal teams and external clients to achieve defined outcomes.

Collaborate Across Functions: Partner with teams in Sales, Marketing, R&D, Human Factors, Risk Management, Quality, and Regulatory to integrate customer requirements and streamline development and submission processes.

Support and Knowledge Sharing: Mobilize support from internal experts to enhance project management, quality, and regulatory. Ensure comprehensive service offerings to pharmaceutical partners.

Align Objectives: Ensure customer needs are met in alignment with Insight's and Nemera's strategic objectives, maintaining active involvement of internal stakeholders.

Provide Expert Guidance: Educate and guide customers on drug delivery systems, quality, and regulatory requirements.

Enhance Industry Understanding: Keep abreast of industry developments and combination products through regular participation in conferences and trade shows.

Maintain Compliance Documentation: Ability to author, review, and approve clear and concise quality and regulatory documents

Oversee regulatory documentation related to combination products to ensure compliance.

Agencies Relationship: Be the point of contact between the company and the regulatory agency - serve as the regulatory liaison.

Effective Communication and Relationship Building: Articulate Quality and Regulatory services benefits to pharmaceutical clients and build lasting relationships with key industry leaders.

There is a travel requirement of up to 30%

Remote working 2 days a week