We are seeking an experienced Regulatory Generalist to join our FSP team as a Senior Regulatory Affairs Associate / Regulatory Affairs Consultant. The role involves working closely with a dedicated client to provide operational support during the IND/NDA maintenance stage. The successful candidate will offer regulatory guidance for developing submissions, ensure the quality and compliance of documents submitted to the FDA, and possess a comprehensive understanding of consulting models and services within the regulatory field.
Key Responsibilities

Provide consulting services within broad project guidelines to address client issues and achieve objectives.
Guide project team members on technical and process issues.
Ensure timely completion of work within scope and quality expectations.
Identify and qualify new client opportunities.
Work independently or within a team, managing issues and conflicts effectively.
Prioritize workload, improve project efficiency, and leverage past project information.
Review and produce quality work that meets client and company standards, mentoring junior staff as needed.
Manage small to larger projects, collaborating with project support staff.
Act as a trusted advisor to clients and colleagues, facilitating decision-making and developing tailored solutions.
Engage professionally at various organizational levels, including senior management.
Identify opportunities for additional business and scope expansion.

Candidate Profile

At least 3 years of experience in the pharmaceutical, biotech, CRO, or life sciences consulting industries, with prior CRO experience preferred.
3+ years in Regulatory Affairs, with experience in preparing and reviewing IND, CTA, MAA, NDA submissions.
Experience with drug information documentation, post-approval variations, and NDA/MA submissions.
Knowledge of FDA and EMA processes, regulations, and interactions.
Experience with project lifecycle management, with a preference for those with small molecule experience.
Familiarity with US and EU regulatory requirements, including pre/post approval submissions, INDs, and aggregate reporting.
Educational background: Bachelor’s Degree in a Scientific or Technical Discipline; an advanced degree is preferred.
Language skills: Fluent in spoken and written English.
Employment contingent on COVID-19 vaccination disclosure and proof, if applicable.

#J-18808-Ljbffr