Regulatory Affairs Manager

Company Description

Zenith Health Science - FZCO (ZHS) is a hybrid B2B pharmaceutical venture created by industry veterans with over 25 years of experience. The company's specialty lies in launching complex generic products that face low competition in the market.

To develop and manage all global regulatory strategies, oversee the preparation and submission of compliant dossiers, and manage interactions with health authorities to secure timely approvals. They monitor evolving regulations, assess their impact on products, and guide cross-functional teams to ensure ongoing compliance throughout the product lifecycle.

Job Location:

Role:

Key Responsibilities:

1. Regulatory Strategy & Planning

• Develop and execute regulatory strategies to enable efficient product development and approvals.
• Assess global regulatory requirements and provide clear strategic guidance to cross-functional teams.
• Plan, coordinate, and review high-quality regulatory submissions and authority interactions.
• Anticipate regulatory risks, monitor evolving guidelines, and integrate insights into strategic planning.

2. Dossier Preparation & Submission

• Compile and review CTD/eCTD dossiers by integrating high-quality CMC, nonclinical, and clinical documentation
• Ensure all submission modules comply with global regulatory guidelines, regional requirements, and technical standards.
• Coordinate cross-functional inputs (CMC, Clinical, Safety, QA) to deliver timely, compliant regulatory submissions.
• Manage lifecycle submissions and respond to health authority queries to support smooth evaluation and approval

3. Agency Engagement & Partner Coordination

• Plan and lead interactions with global health authorities, ensuring clear, aligned regulatory communication.
• Prepare high-quality briefing documents and meeting strategies to support successful agency engagements.
• Coordinate seamlessly with internal teams and external partners to align on regulatory expectations and deliverables.
• Manage partner and agency queries efficiently to maintain compliance, transparency, and program momentum.

4. Lifecycle Management

• Manage post-approval activities such as variations, renewals, and labeling updates to ensure ongoing product compliance.
• Coordinate with CMC, Safety, Quality, and Commercial teams to support seamless lifecycle maintenance.
• Monitor regulatory changes and implement required updates to maintain market continuity and compliance.

5. Compliance & Intelligence

• Maintain compliance by ensuring alignment with current guidelines and submission standards.
• Provide periodic update on impact and compliance to regulatory head.
• Support regulatory inspections as needed.

6. Cross-functional Collaboration

• Partner with CMC, Clinical, Safety, and Quality teams to align on regulatory strategies and requirements.
• Ensure timely cross-functional coordination for data, documentation, and submission readiness.
• Support business development activities, due diligence, and partnership evaluations for the region.