Director, CMC Regulatory Affairs (Hybrid/Remote)
Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.
As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.
Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.
- The Director CMC Regulatory Affairs leads the coordination, review, and compilation of CMC sections in support of customer ANDAs/NDAs, INDs, and Annual Reports. The role ensures current and timely updates to licenses, registrations, and listings in support of Quotient operations and customer’s global regulatory strategies.
Main tasks and responsibilities will include:
- Serve as functional CMC representative on assigned new project teams and related technical workstreams. Actively contribute to customer regulatory strategies for assigned projects. Provide technical guidance to the development and implementation of clinical and CMC regulatory strategy for projects in all stages of the product lifecycle (pre-IND/IMPD through commercial).
- Participate in and collaborate as author in the preparation of customer’s CMC regulatory submission documents, including INDs, marketing applications, post-market changes (SUPAC), and scientific advice in adherence with applicable regulations and guidelines for submission to health authorities. Serve as the primary review for customer’s CMC sections of regulatory submissions, drawing upon the expertise of other functions as needed, and assure technical accuracy and regulatory compliance of documents.
- Liaise with other internal and external SME’s to advise on strategy and content for IND CMC drug product sections describing clinical trial materials to be manufactured by Quotient Sciences, reviewing prior to submission to ensure they meet current regulatory expectations and guidance.
- Serve as the point of contact with customers and regulatory authorities with respect to market applications and registrations. Prepare documents necessary to support customer filings and, as required collaborate on review and responses to questions and deficiency letters.
- Maintain visibility of customer regulatory strategies in support of their global product distribution and sales plans of commercially available product. Manage application processes to obtain necessary licenses and registrations (domestic and international) in support of customer sales and ensure site compliance to required regulations and standards prior to filings. Establish and maintain database for license and registration tracking.
- Assess and communicate all CMC-related requirements to stakeholders to maintain compliance without delay to business due to Regulatory issues. Collaborate with site and global leaders to ensure regulatory compliance to global regulations is achieved in timeframes necessary to support customer filings.
- Maintain FDA registrations including facility registration, GDUFA Self Identification, Labeler Code Updates, and Drug Listings.
- Execute activities and liaise with customers to maintain compliant regulatory status for their marketed products portfolio. Prepare annual reports, review change controls, and, as necessary, support supplement filing (CBE-0, CBE-30, PAS).
- Track costs associated with all facility and product licenses, registrations and listing and collaborate with Finance and Business Development to ensure proper allocation of costs to customers.
- Ensure all work is completed within expected timelines.
- Ensure regulatory processes and procedures are consistently aligned with current regulatory requirements, industry best practices, and support efficient and effective operations.
- Participate in regulatory inspections to ensure successful results.
- Develop productive, dynamic, professional working relationships founded in trust and respect with global and local colleagues, project team members, and customers.
- Serve as an internal subject matter expert with respect to the responsibilities outlined above and train/educate others within the organization on these requirements and expectations.
- Perform other duties as assigned.
- Business Travel required up to 30%
- B.S., M.S., degree in a scientific field, e.g., pharmacy, chemistry, biology, or pharmacology
- Minimum ten (10) years’ CMC related experience in Regulatory Affairs
- Experience in IND submissions, and ANDA/NDA submissions for oral small or large molecule early development (phase 1 and 2) or late stage (phase 3) and commercial applications.
- Working knowledge and experience in the pharmaceutical industry in GMP, GDP, GCP, GLP, GCLP is desirable.
- Experience in importation of API and drug product desired.
- Good working knowledge of the FDA and ICH regulations and guidance for CMC.
- Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
- Thorough knowledge of the drug development process, with a focus on the regulatory CMC processes.
- Experience in maintaining compliant regulatory status for marketed products and managing licensing and registration processes to support global distribution and sales.
- Excellent verbal and written communication and skills.
- Ability to work collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
In return you will receive a competitive salary, a generous benefits package, excellent training, and development, as well as an exciting career within a fast paced and dynamic business.
Our Commitment to Diversity & Inclusion
Quotient Sciences are advocates for positive change and conscious inclusion.
We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.
As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.
If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at email@example.com.