Work Schedule Environmental Conditions Job Description

Join Us as a Regulatory Affairs Manager – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100 countries in the last 5 years.

• Responsible for providing Regulatory CMC expertise into the development and implementation of the global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products. Responsibilities include developing and implementing regulatory strategies, authoring / reviewing of quality submission packages, ensuring their accuracy and timely delivery, and coordinating responses to health authorities for the company’s large molecule therapeutic drug candidates throughout their clinical development towards marketing approval as well as global life cycle management projects. Additionally, the job requires strong communication and coordination with external partners, contributing to risk assessments and mitigation strategies. In this role you will have a front seat in the heart of a development/commercial organization and able to weigh into CMC development strategies.

Demonstrates strong leadership, effective cross-functional collaboration, and excellent communication skills.

ROLES AND RESPONSIBILITIES:

• Develop, plan and execute appropriate regulatory strategies of pre-clinical, clinical (early to late stage), and commercial stage programs in close collaboration with the regulatory sub-functions, quality and CMC team members.
• Responsible for preparing and managing CMC regulatory submissions (including IND/IMPD/CTAs), ensuring submissions are accurate, complete, and timely in accordance with regulations and procedures,
• Coordinate, write and review responses to regional and global Health Authorities to ensure timely submission.
• Participate to the authoring and preparing IND, IMPD, scientific briefing documents, Investigator Brochures and regulatory agency response documents for therapeutic compounds in development in close collaboration with external and internal stakeholders.
• Participate to the authoring and preparing BLA, J-MAA, MAA and ROW applications (module 2 and 3) and related life cycle documents.
• Coordinating activities with external partners ensuring that deliverables are executed with the right priorities and to the required standards and maintain open lines of communication on assigned projects/products to ensure awareness on status and issues relating to submissions. Providing strategic input into CMC risks assessment and mitigation plans and ensuring they remain in line with the overall global Regulatory CMC strategy.
• Conduct regulatory assessments for CMC change controls and oversee submission of amendments for clinical phases.
• Tracking execution of regulatory Commitments.

Education and Experience Requirements:

• University degree in  life sciences or related health sciences (BS/BA/MS or equivalent, PhD), a degree in Regulatory Affairs is advantageous.

• 8 years regulatory experience in the pharmaceutical/health care industry. 5 years Regulatory CMC experience.

• Sound knowledge in life sciences with a focus on biological/vaccines/ complex small molecule/gene therapy medicinal products.  Experience in plasma related products is an advantage.

• Strong technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, Switzerland, Australia, China, and Rest of World).

• Strong regulatory CMC authoring skills and able to evaluate technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements.

• Strong knowledge in Good Manufacturing Practice or related areas.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Excellent English language (written and oral) communication skills as well as local language where applicable

• Excellent attention to detail and quality as well as excellent editorial/proofreading skills

• Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments

• Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies

• Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects

• Excellent negotiation skills

• Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables

• Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; advanced understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.

• Superb understanding of medical terminology, statistical concepts, and guidelines

• Excellent analytical, investigative and problem-solving skills

• Excellent understanding of budgeting and forecasting

• Must be familiar and able to work with RIMS (e.g Veeva RIMS), eDMS (e.g. Veeva, Documentum) and Change Management (e.g. Trackwise) systems.

Working Conditions and Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.