Oversees Regulatory Affairs activities for the contract development and manufacturing organization (CDMO) where GRAM's clients are the sponsors, application- and license- holders for sterile injectable products, from clinical through commercial phases. Manages a broad spectrum of projects to support the regulatory needs of GRAM and GRAM's clients. This position interacts with all internal departments within GRAM and with external clients, suppliers, contractors, and regulatory agencies. This position does not oversee direct reports.
ESSENTIAL DUTIES & RESPONSIBILITIES
Maintain current knowledge of all relevant regulations (21CFR Parts 11, 210, 211, 600 and applicable guidance documents) while also monitoring any changes that occur which may impact products manufactured as well as assess and communicate regulatory requirements to stakeholders in order to maintain compliance without delay to business due to regulatory issues. Ownership of GRAM's Regulatory Intelligence process
Provide regulatory CMC support to GRAM clients, including providing documents for filings and review of client submissions on behalf of GRAM; ensure submissions are aligned with GRAM's supply agreements (e.g. clinical, commercial, markets). Submit and maintain letters of authorizations (LOA) for GRAM's clients to reference a Type V Drug Master File in submissions.
Maintain and manage existing FDA establishment registrations and product listings (NDC, SPL), filing/obtaining new registrations as required. Generate and maintain NDC codes for GRAM's commercial products manufactured.
Stakeholder of GRAM supply and quality agreements, providing input and ensuring alignment with regulatory requirements.
Responsible for submitting annual GDUFA self-identification(s) to FDA.
Maintenance of GRAM's Type V Drug Master File (sterile processing facility), including amendments, annual reports; and LOA.
Maintenance of Site Master Files for GRAM's facilities.
Support BD due-diligence evaluation of new business opportunities; participate in potential-client visits to assess regulatory impact and provide meaningful contributions to the new-business selection process.
Develop and maintain SOPs, work instructions, forms and other documentation and training materials related to Regulatory Affairs.
Oversight and administration of GRAM's controlled substance management program and infrastructure, according to the Drug Enforcement Agency (DEA) regulations.
Perform Regulatory Assessments for GRAM's holistic change control process.
Participate in regulatory audits, including response writing to observations and follow up as applicable.
Write, revise, review relevant departmental SOPs and associated documents.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
Perform all other tasks, projects, and duties as assigned.
DESIRED SKILLS & ABILITIES
Candidate with prior or current roles within or working closely with a CMO/CDMO preferred.
Knowledge of cGMP, ICH, and USP regulations or guidelines.
Experience with international pharmaceutical regulations desired (TGA, ANVISA, JP, EMA, Health Canada, etc.)
Advanced knowledge of quality standards (FDA 21 CFR 11, 210, 211, 600; Eudralex vol 4, Annex 1, PIC/S) statistical analysis, root cause analysis, quality measurement, CAPA, SPC, FMEA.
Knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
Proficiency in both written and verbal communication and presentations.
Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
Prior experience preparing FDA correspondence, briefing packages and conducting meetings with the Agency desirable.
Regulatory Affairs Certification (RAC) desired.
Member of pharmaceutical trade associations such as RAPS, ISPE, PDA, etc. desirable.
Results oriented and efficient.
Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
Ability to work closely with a diverse customer base (internally and externally).
Ability to work well in a cross-functional team environment.
Must have proficient computer skills in Microsoft Word, Excel and Outlook.
Working knowledge of regulatory requirements (e.g. FDA/ICH, GMP regulations, GDUFA) and familiarity with US regulatory submissions for ANDAs, NDAs, DMFs, CRL/DRL/IR ANDA review responses, post-approval supplements and pre-ANDA meeting packages.
Proven ability to write effective responses to FDA application review questions to minimize the number of review cycles.
Knowledgeable in regulatory science and ANDA data requirements of all phases of product development for sterile parenteral products.
Highly competent to perform critical reviews of regulatory applications and submissions for GRAM's client's regulatory correspondence.
Must be entrepreneurial and resourceful and be able to work through complex, enterprise level issues with a systematic approach.
Excellent interpersonal communication skills and well-developed collaborative management skills that are effective in working with BD, Project Management, Quality and RA professionals across diverse organizations.
Excellent technical writing skills.
Qualified candidates have attained a Bachelor's Degree in Life Sciences or related field and have a minimum of 10 years of experience in the pharmaceutical industry and 6 years of hands on experience in Regulatory Affairs with increasing responsibilities.
GRAM supports Equal Opportunity Employment