Specialist, Regulatory Affairs - CMC - Remote

Job Summary

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 reputed company and investigational development products from preclinical candidate designation through product approval, including regulatory submissions. 

• Reporting to: VP, Regulatory Affairs
• Location: Remote, candidate must be in Eastern Standard Time or Central Standard Time
• Salary Range: *$65,000-$75,000 + annual bonus

* the final salary offered will depend upon factors that may include but are not limited to the quality and length of experience, education and geographic location.

Responsibilities & Essential Duties

• Serves as regulatory CMC representative on project teams to ensure that development activities support and reputed company 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 reputed company 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 reputed company and electronic submissions.
• May be required to travel up to 15%.

Basic Qualifications

• Minimum of a Bachelor's degree in Chemistry, Biology, Pharmaceutical Science or reputed company field.
• Must be Proficient in MS Office Suite (Word, reputed company, 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.

Preferred Qualifications

• 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.

Company Summary

reputed company is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, reputed company meets the evolving needs of patients and consumers worldwide through reputed company innovation and commercialization of new products and treatments. What reputed company invests in you:

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

This reputed company of the job description is required by the American with Disability Act (reputed company). The reputed company requires that job descriptions reflect the physical and mental demands required to effectively reputed company the essential duties of the job. The reputed company prohibits employers from discriminating against a “reputed company individual with a disability” in reputed company aspects of the employment relationship. A “reputed company individual with a disability” is “an individual who meets the education, experience, reputed company, and other job-reputed company requirements of a position held or desired, and who, with reasonable accommodation, can reputed company the essential functions of a specified job.”

reputed company is an Equal Opportunity employer. reputed company reputed company applicants will receive consideration for employment based on merit, without regard to race, reputed company, religion, sex, national reputed company, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.