Specialist, Regulatory Affairs - CMC - Remote

Revance • Nashville, TN

5d • $65,000 - $75,000 • Remote

About The Position

We are looking for a Specialist, Regulatory Affairs - CMC to join our Regulatory team. The position is responsible for the Regulatory Affairs activities (nonclinical, clinical and CMC) for assigned commercial and investigational development products from preclinical candidate designation through product approval, including regulatory submissions.

Requirements

• Minimum of a Bachelor's degree in Chemistry, Biology, Pharmaceutical Science or related field.
• Must be Proficient in MS Office Suite (Word, Excel, PowerPoint, Outlook).
• 0-2 years of experience in Regulatory Affairs.
• Strong written and verbal communication, organizational, and people skills.
• Demonstrate strong analytical, problem-solving skills, and attention to detail.
• Ability to work cross-functionally and manage multiple projects simultaneously.

Nice To Haves

• Regulatory Affairs Certification or equivalent training.
• Experience in pharmaceutical Regulatory Affairs with a focus in drugs/biologics.
• Experience in preparation, submission and lifecycle management of investigational/marketing applications in eCTD format.
• Knowledge of US, EU, Health Canada, and ICH regulatory requirements.
• Experience directly interfacing with regulatory authorities.

Responsibilities

• Serves as regulatory CMC representative on project teams to ensure that development activities support and comply with the relevant regulatory requirements.
• Reviews proposed CMC changes and assesses regulatory impact and filing requirements.
• Supports the preparation, submission, and management of regulatory filings (INDs, CTAs, BLAs, etc.) to health authorities.
• Collaborates on submission content with contributing authors across functional areas to achieve clarity and regulatory compliance (INDs, CTAs, BLAs/NDAs, meeting packages, responses, supplements, annual reports).
• Ensures timely preparation of organized and scientifically valid applications.
• Contributes to the development of internal regulatory CMC guidance and SOPs.
• Reviews/contributes to product development plans for assigned submissions/products.
• Interacts with regulatory agencies on defined matters.
• Responsible for executing regulatory documentation infrastructure, including paper and electronic submissions.
• May be required to travel up to 15%.

Benefits

• Competitive Compensation including base salary and annual performance bonus.
• Flexible PTO, holidays, and parental leave.
• Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 251-500 employees