Manager, Regulatory
Invivyd
4 days ago
Remote friendly (New Haven, CT)
United States
$120,000 - $160,000 USD yearly
Corporate Functions
Responsibilities:
- Execute regulatory strategies, including compiling regulatory submissions (IND, CTA, Amendments) and supporting major submissions such as (s)BLA, MAA, and variations in compliance with applicable requirements.
- Lead the compilation of agency interaction documents (Meeting Requests and Meeting Packages).
- Lead the Labeling Working Group for assigned submissions, responsible for USPI annotations and mockups.
- With the global regulatory team, assist with regulatory activities for assigned projects covering clinical, non-clinical, and CMC.
- Organize and maintain regulatory files in the regulatory information management (RIM) system to ensure compliance.
- May guide associates/contractors on regional requests and documentation.
Requirements:
- BA/BS in biological/physical sciences (advanced degree preferred).
- 5+ years of relevant Regulatory Affairs experience in biotech/pharma.
- Strong understanding of drug development and pharmaceutical regulatory requirements/policy.
- Strong written/oral communication and organizational skills; ability to prioritize across multiple projects and timelines.
- Ability to analyze complex scientific/regulatory information and formulate recommendations.
- Proven ability to work independently and collaboratively in a fast-paced, matrixed environment.
- Experience leading regulatory submissions and agency interactions.
- Document management/RIM experience; Veeva Vault (RIM Suite) preferred.
- Proficient with MS Office.
- Strong problem-solving skills and attention to detail.
- Ability to present professionally to stakeholders, including regulatory authorities.
- Work onsite at least 1x/week in New Haven HQ.
Pay Range:
- $120,000–$160,000 base salary; eligible for annual short-term incentive and annual long-term incentive (e.g., equity).
- Execute regulatory strategies, including compiling regulatory submissions (IND, CTA, Amendments) and supporting major submissions such as (s)BLA, MAA, and variations in compliance with applicable requirements.
- Lead the compilation of agency interaction documents (Meeting Requests and Meeting Packages).
- Lead the Labeling Working Group for assigned submissions, responsible for USPI annotations and mockups.
- With the global regulatory team, assist with regulatory activities for assigned projects covering clinical, non-clinical, and CMC.
- Organize and maintain regulatory files in the regulatory information management (RIM) system to ensure compliance.
- May guide associates/contractors on regional requests and documentation.
Requirements:
- BA/BS in biological/physical sciences (advanced degree preferred).
- 5+ years of relevant Regulatory Affairs experience in biotech/pharma.
- Strong understanding of drug development and pharmaceutical regulatory requirements/policy.
- Strong written/oral communication and organizational skills; ability to prioritize across multiple projects and timelines.
- Ability to analyze complex scientific/regulatory information and formulate recommendations.
- Proven ability to work independently and collaboratively in a fast-paced, matrixed environment.
- Experience leading regulatory submissions and agency interactions.
- Document management/RIM experience; Veeva Vault (RIM Suite) preferred.
- Proficient with MS Office.
- Strong problem-solving skills and attention to detail.
- Ability to present professionally to stakeholders, including regulatory authorities.
- Work onsite at least 1x/week in New Haven HQ.
Pay Range:
- $120,000–$160,000 base salary; eligible for annual short-term incentive and annual long-term incentive (e.g., equity).