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 commercial 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 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%.    Basic Qualifications: 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.  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: Revance 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, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments. What Revance invests in you: 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! This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job.

The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.” Revance is an Equal Opportunity employer.

All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.  

Revance Therapeutics (NASDAQ: RVNC) is a leading biotechnology company focused on transforming the field of neuromodulators and aesthetic medicine. With a commitment to innovation and scientific advancement, Revance Therapeutics is revolutionizing the way patients experience facial rejuvenation and therapeutic treatments.

Through its cutting-edge technology and research, the company is setting new standards in the industry and driving the future of medical aesthetics.