Manager, Regulatory Writing

The Manager, Regulatory Writing, is responsible for contributing to regulatory messaging strategy and overseeing the regulatory writing for assigned programs to support submissions and business objectives. Reporting to the SVP, Regulatory Affairs, this role will work cross functionally to provide writing support in the creation of effective and timely communications that meet all applicable regulatory requirements.

DUTIES AND RESPONSIBILITIES:

Independently manage regulatory writing activities across assigned programs. Author or oversee the authoring of all regulatory submission documents including but not limited to, Briefing documents, IND/CTA supporting documents, and CTD/BLA/MAA documentation for eCTD compliant submissions.

Comply with internal and external processes and guidelines while managing the writing review process and resolving issues, errors, or inconsistencies with pertinent team members to ensure timely completion and quality of assigned documents.

Lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications.

Manage and coordinate all external writers supporting assigned programs to ensure consistency of messaging and timely delivery of documents per project plans.

As assigned, perform Quality Control (QC) review of documents which are part of various regulatory submissions. Examples include looking for typographical, grammatical/spelling, formatting, flow and general clarity of text.

Generate document timelines.

Other duties as assigned.

EDUCATION AND EXPERINCE:
Bachelor’s degree in life sciences or relevant field.
4+ years of experience in regulatory affairs writing in the Biotech/Pharmaceutical industry.

Strong understanding of global regulatory requirements.

DESIRED KEY

COMPETENCIES:

Ability to understand and execute the company’s mission and values.

Self-motivated and independently minded. Strong verbal and written communication skills and cross-functional collaboration abilities.

Self-organizer, meticulous hands-on habits, keen attention to detail. Ability to build working relations throughout the organization to achieve business goals. Strong time management, organizational, and execution skills.

Ability to manage multiple projects in a fast-paced environment. Excellent judgement and decision-making skills.

Problem solving and risk-mitigation skills. EOE MFDV