US ~ Garnet Valley, PA
Senior Regulatory Affairs Specialist
Our growing and successful business comprises of over 800 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
- 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 in order 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-30, CBE-0, 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.
Main tasks and responsibilities will include:
- Support early client discussions with a focus on our formulation development and manufacturing capabilities from candidate selection through to commercial manufacture
- Review data packages provided by customers to understand the pharmaceutical development needs of new molecules based on first principles
- Own/lead pharmaceutical science program design activities, working with other scientific, technical, and operational resources in the business as required
- Accountable for providing complete and high quality information to Client Services to allow on time generation of high quality proposals
- Communicate Quotient’s go-to-market messaging to promote our unique ability to combine and integrate capabilities to reduce the time and cost of development and accelerate medicines to patients
- In all customer interactions seek to convey scientific thought leadership status to be able to win trust with senior stakeholders, influence thinking and program design, positioning Quotient’s services and capabilities as value-add differentiators
- Ensure Quotient’s capability to move molecules through to commercial are fully articulated during early program scoping discussions, to maximise these opportunities being realized by Quotient
- Where required, provide scientific oversight and support to project teams for projects during operational delivery to ensure objectives are achieved
- Share key project learnings within Quotient
- Listening to the marketplace, help drive strategic initiatives enabling Quotient to become the partner of choice for drug development services.
- Work with marketing and Global VP Pharm Sci to create/update external communication materials and content and support external events to drive marketplace awareness and customer adoption of Quotient’s services
- B.S. degree in a scientific field, e.g., pharmacy, chemistry, biology, or pharmacology
- Minimum five (5) years’ CMC related experience in Regulatory Affairs
- Experience in IND submissions, and ANDA/NDA submissions for oral small molecule development desired
- RAC desired
- 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.