Regulatory Affairs Assoc II CMC

United Kingdom - Cambridge Regulatory Regular

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

This exciting role of Regulatory Affairs Associate II, CMC sits in Gilead's CMC Regulatory Affairs - Small Molecule Group. Responsibilities and qualifications are as follows:

• 
  
• Provides support for designated regional regulatory activities for PDM CMC Project and Commercial Teams, Regulatory Project and Regulatory Submissions Teams, with focus on Small/Synthetic Molecules.
  
• Assists designated CMC RA leads in identifying and ranking risks, proposing risk mitigation plans. Shadows leads while they develop and execute robust CMC regulatory strategies.
  
• Under the guidance of more senior staff, oversees the preparation of CMC regulatory submissions for investigational and commercial products with solid scientific foundations, in compliance with ICH and regional requirements, and in alignment with company policies and procedures.
  
• Will become proficient in utilizing computerizing systems as per established business processes, both within and outside of the GxP environment.
  
• Will train and learn how to prepare regulatory submissions which require some interactions with other members in the CMC regulatory department for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.
  
• Will perform workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the CMC regulatory department.
  
• Participates in group meetings and provides tactical approaches to addressing issues of low to moderate complexity.
  
• May participate in other Subteams and in non-product related projects; may contribute to local process improvements, which have an impact on the working of the CMC Regulatory function or other departments.
  
• Learns how to interpret regulatory guidelines and how to comply with statutory requirements.
  
• Learns how to provide regulatory impact assessments for changes managed in the quality systems and participates in technical risk assessment exercises.
  
• Proactively invests in own development to acquire regulatory skills and knowledge, with manager support.
  
• Invests in acquiring knowledge about CMC regulatory intelligence including guidelines and regulatory trends.
  

• 
  
• Ph.D., Masters or Bachelor's in pharmacy, chemistry or related field with experience working in scientific/technical group within a pharma company.
  

• 
  
• Experience with small molecule/synthetic pharmaceuticals would be preferred.
  
• Collaborative, proactive, and highly organized approach to work.
  
• Demonstrated track record with strategic planning, problem solving, and working within a global matrix team environment.
  
• Good understanding of the drug development process.
  
• Excellent verbal and written communication skills and ability to interact well with colleagues and stakeholders.
  
• Experience in a GMP environment is preferred.
  
• Ability to learn on the job is preferred.
  

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.