Senior Manager, Regulatory Affairs - EU

Gan & Lee Pharmaceuticals; United States; Remote; USD 120,000 - 160,000; Full time

Job summary

A leading pharmaceutical company is seeking a Regulatory Affairs Lead responsible for developing regulatory strategies and managing submissions for investigational products. The role requires substantial experience in regulatory CMC processes and familiarity with both US and EU regulations. The successful candidate will collaborate with cross-functional teams and lead regulatory discussions with authorities to ensure compliance.

Qualifications

• 7-8 years of pharmaceutical industry experience.
• 4-6 years of regulatory CMC experience with US product development.
• Deep knowledge of EU and US regulations for drugs and biologics.

Responsibilities

• Contribute to regulatory strategies for Clinical Trial Applications and other filings.
• Participate as Global Product Strategy Lead in cross-functional teams.
• Manage submission dates and communications with regulatory authorities.

Skills

Project Management

Analytical Skills

Relationship Building

Strategic Thinking

Independent Operation

Microsoft Office Proficiency

Education

Bachelor of Science Degree in a relevant area

Advanced Science Degree (preferred)

RAC Certification (preferred)

Job description

Summary
This position reports to the Functional Area Head, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain interactions with regulatory agencies.


Education and Credentials
• Bachelor of Science Degree in a relevant area is required. Advanced science degree is preferred.
• RAC certification or other equivalent is preferred.

Experience

• Minimum Bachelor’s degree in a scientific or related discipline, at least 7~8 years of pharmaceutical industrial experience, at least 4~6 years of regulatory CMC experience with US product development.
• Deep knowledge of EU and US regulations for drugs and biologics.
• Familiarity with GLP/GCP/GMP, clinical laboratory regulations, and licensing.
• Experience in various regulatory submissions and communication with regulatory agencies. Hosted communication with the agencies on clinical development plans, clinical design and other clinical aspects (including document package writing, meetings and discussions with the agency, etc.) is preferred.
• Led at least one drug CTA application in EU and got it approved. Experience in endocrine drugs such as insulin and GLP-1 is preferred.
• Experience in working in multi-culture/multi-countries environment is preferred.

Skills

• Demonstrated ability to manage multiple and diverse projects concurrently.
• Demonstrated ability to develop positive relationships and collaborations.
• Strong analytical skills; a strategic thinker, planner, and implementer.
• Ability to operate independently with minimal supervision.
• Strong proficiency in major Microsoft Office products (i.e., Word, Excel, PowerPoint, Project).
• Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals.

Responsibilities

1. Actively contribute to the development of regulatory strategies for investigational products in Clinical Trial Applications (CTA) / Investigational New Drug (IND)/, Marketing Authorization Application (MAA) / Biologics Licensing Application (BLAs), through evaluating scientific merits of Chemistry, Manufacturing and Control (CMC) and nonclinical study data package;
2. Participate as Global Product Strategy Lead in cross-functional teams, including but not limited to, contract research organizations (CROs), functional working groups, global regulatory team, submission team, product development team, to ensure compliance with regulatory requirements;
3. Author Module 2 and 3 documents for regulatory filings such as IMPDs/ CTAs/ MAAs/IND/NDAs/ global registrations and eCTD submissions, ensuring that they meet current regulatory standards.
4. Drive the preparation and review of regulatory discussion meetings with EMA, EU Competent Authorities and US FDA such as EMA scientific advice request, BfArM pre-CTA request, IND meetings
5. Manage and track filing submission dates, questions from Regulatory Health Authorities, responses, and approval dates.