Regulatory Affairs Manager - Boston, MA, United States - Atea Pharmaceuticals Inc.

Description

The Director Regulatory CMC will be responsible for developing and delivering innovative regulatory CMC strategies for product development and approval.

With limited guidance from the EVP Regulatory Affairs & Quality Assurance, the incumbent acts as the regulatory CMC expert for assigned products.

The individual will have regulatory CMC experience in the development of small molecule products and writing CMC sections for IMPDs, INDs and/or NDAs.

Acts as the regulatory CMC expert for assigned products.
Develops the global regulatory CMC strategy for CTA/INDs, NDA/MAAs, Health Authority meetings, etc.
Collaborates on the development and/or optimization of product development strategy to be consistent with regulatory requirements.

Determines and gains alignment with the CMC team on the required content for CMC dossiers and timelines in conjunction with overall clinical strategy/development of development candidates.

Supports dossier preparation, review and publishing processes in line with project timelines to deliver high-quality submissions.
Interacts with regulatory authorities and external partners to address CMC regulatory strategy, milestone meetings, queries and regulatory actions.
Collaborates on authoring Standard Operating Procedures and developing internal processes for the regulatory affairs department.
Good organizational skills, proven ability to multi-task, excellent written and verbal communication skills in English.
Understanding of scientific principles and regulatory CMC requirements relevant to global drug development.
Prior experience in regulatory filings, approvals, and strategic planning.
Basic computer skills (MS Office, MS Teams, MS Excel, MS PowerPoint and Adobe Acrobat). Demonstrates the ability to check regulatory documents to determine accuracy and find potential errors.
Ability to communicate clearly and concisely with senior management and regulatory authorities.
University degree in a scientific/technical discipline with a minimum of eight years of experience in the pharmaceutical industry.
Experience writing Module 3 sections.
Familiarity/understanding of global regulatory agencies (e.g.

Currently, we are focused on the development of orally available, potent, and selective nucleotide prodrugs for difficult to treat, life-threatening viral infections, including SARS-CoV-2, the virus that causes COVID-19, chronic hepatitis C infection ("HCV"), dengue virus, and respiratory syncytial virus ("RSV").

We are currently utilizing a remote/hybrid work environment.

For employees located in the Boston area, we use a hybrid work schedule and we are located at a newly built work site at 225 Franklin Street in Boston.

For employees not located in the Boston area work will continue to be performed remotely. Normally, work is performed in a typical office environment with heavy computer duties. Infrequent travel may be required after pandemic risk subsides.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents.

Atea Pharmaceuticals, Inc.

provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.

In addition to federal law requirements, Atea Pharmaceuticals, Inc.

complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.

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