Sr. Regulatory Affairs Specialist

Description

Quality, Service, Collaboration, Courage. Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded culture? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day.

Overview of this Position:

The Sr. Regulatory Affairs Specialist 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. This is not a remote role.

Non-Negotiable Requirements:

• Bachelor's degree in Life Sciences or a related field
• 5+ years of experience in a regulated (pharmaceutical/medical device) industry with hands-on experience in Regulatory Affairs with increasing responsibilities.
• Working knowledge of regulatory requirements (e.g., FDA/ICH/EUGMP regulations, GDUFA) and familiarity with regulatory submissions for INDs, ANDAs, NDAs, DMFs, CRL/DRL/IR ANDA,EU variation review responses, post-approval supplements and pre-submission meeting packages.
• Knowledgeable in regulatory science and submission data requirements of all phases of product development for sterile parenteral products.
• Knowledge of cGMP, ICH, and USP regulations or guidelines.
• Excellent technical writing skills.
• Prior experience preparing FDA correspondence.

Preferred Requirements:

• Candidate with prior or current roles within or working closely with a CMO/CDMO preferred.
• Experience with international pharmaceutical regulations desired (TGA, ANVISA, JP, EMA, Health Canada, etc.).
• Regulatory Affairs Certification (RAC).
• Member of pharmaceutical trade associations such as RAPS, ISPE, PDA, 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.

Responsibilities Include (but are not limited to):

• Maintain current knowledge of all relevant regulations (21CFR Parts 11, 210, 211, 600, 820 and applicable guidance documents, EudraLex Volume 4) while also monitoring any changes that occur which may impact products manufactured as well as access and communicate regulatory requirements to stakeholders in order to maintain compliance without delay to business due to regulatory issues.
• 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 FDA approved commercial products for Cares Act Reporting.
• Facilitate GRAM Client 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.
• Maintenance of Site Master Files for GRAM's facilities.
• Support BD due-diligence evaluation of new business opportunities 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.
• Perform Regulatory Assessments for GRAM's holistic change control process.
• Write, revise, review relevant departmental SOPs, SWIs and associated documents.
• Support Agency, customer and vendor audits as needed.

Full job description available during formal interview process.

What Sets GRAM Apart from Other Employers:

MEDICAL BENEFITS starting day 1: Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying for 75% of the cost! Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well. We also offer generous off-shift premiums!

Paid VOLUNTEERISM starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year!

PTO: Full-time employees accrue up to 13 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!

WELLNESS TIME OFF: Employees earn 1 hour of time off for every 30 hours worked to use how you choose.

PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility!

PAY: Depends on Experience and is discussed during the interview process.