Manager Regulatory Affairs - Combination Products

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