[Remote] Specialist, Regulatory Affairs - CMC - Remote
Note: The job is a remote job and is reputed company to candidates in USA. 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. The Specialist, Regulatory Affairs - CMC will be responsible for Regulatory Affairs activities for assigned reputed company and investigational development products from preclinical candidate designation through product approval, including regulatory submissions.
Responsibilities
- 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 reputed company 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 reputed company
- Responsible for executing regulatory documentation infrastructure, including reputed company and electronic submissions
- May be required to travel up to 15%
Skills
- 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
- 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
Benefits
- 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!
Company Overview
Company H1B Sponsorship