Senior Manager, Regulatory Affairs

Job Description
Job Description

This position is responsible for all aspects of regulatory affairs as directed by the supervisor.



Essential Duties and Responsibilities

Develops global regulatory strategies and product development pathways for pre-clinical and clinical teams.

Makes regulatory recommendations and decisions based on knowledge of regulations and experience.

Frequently interacts with internal management and external collaborators concerning projects, including operational and contractual issues.

Coordinates and communicates with regulatory counterparts of collaborators.

Manages regulatory CROs and contractors.

Develops budgets, schedules, and procedures.

Held accountable for meeting department objectives and deadlines.

Manages cross-functional preparation and submission of high-quality documents to global regulatory authorities, including: INDs, IND Annual Reports, Drug Safety Update
Reports, IBs, IMPDs, Orphan Drug applications, Clinical Trial Applications, and GMO applications.

Prepares and submits paper INDs and amendments to FDA

Researches country-specific requirements and processes for approving and conducting clinical trials.

Maintains regulatory document files.

Writes Regulatory Affairs SOPs.

Reviews investigator regulatory documents and approves drug shipment to clinical sites.

Reviews and interprets new regulatory guidance’s, regulations, and polices; evaluates their potential impact on the company; and informs appropriate functional areas.

Attends FDA workshops and public hearings and reports back to company.

Exercises sound judgment based on professional experience and maintains high ethical standards in all duties performed for Aeras.


Qualifications

BS in a scientific discipline.

7-9 years work experience in global, biologic Regulatory Affairs; vaccine experience a plus.

Knowledge of FDA, EMA, and ICH guidances and regulations.

Strong written and verbal communications skills.

Experience in managing complex projects with multiple tasks and shifting priorities.

Experience in providing regulatory strategies to multidisciplinary teams; technical expertise a plus.

Ability to work independently and as part of a cross-functional team.

Proficiency in MS Office.

Detail-oriented.

Adaptable.

Ability to travel, as necessary.

Company

Aeras

Job Code

State or Province

Maryland

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