Specialist, Regulatory Affairs-Operations

Job Description

About The Role:

Forge Biologics, Inc. seeks an experienced Regulatory Affairs Specialist to join our growing team. This role will be accountable for the preparation and management of CMC (chemistry, manufacturing, and control) components for dossiers and submissions of Module 2.3 and Module 3 CTD (common technical document) sections, Drug Master Files (DMFs), Site Master Files (SMFs) and related progress reports, amendments, supplemental applications. This includes continued maintenance of these CMC regulatory submissions to the FDA, Health Canada, MHRA, EU Health Authorities including EMA and other global regulatory agencies. This role works across functional groups and directly with external client teams to propose strategies and solutions. Responsibilities include coordination and management of CMC change control and related databases for clinical and commercial applications. The position will support compliance with regulatory authority regulations and interpretations with opportunities to interact with clients of Forge Biologics and global regulatory agency personnel.

A strong candidate will demonstrate independent project management, document creation and lead the integration of regulatory filings with various teams including operations, quality, external clients, and external CROs and consultants in the planning, organization, and preparation of regulatory documents. Excellent written and effective verbal communication skills along with flexibility and ability to work in a fast-paced environment are a must.

What You'll Do:

Assist in the technical review and preparation of various investigational drug, marketing applications and other formal reports for submission to regulatory agencies

Ensure that the content and structure of documents meet established regulatory requirements

Actively contribute to the development and implementation of regulatory strategy for assigned projects.

Liaise as CMC representative across functional groups, client teams, international regulatory groups and business partners, propose strategies and solutions at level of personal technical experience and identify issues that may delay project timelines

Provide support for other members of the department on the basis of workload.

Prepare, coordinate, manage or maintain regulatory CMC documentation submissions (e.g., Module 2.3 & Module 3 CTDs, DMFs, amendments, annual reports, meeting packages, etc.) in accordance with applicable regulations; this includes ability to translate regulatory requirements into practical, workable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival).

Provide thoughtful & accurate comments during document development and review, aware of regulatory/USP/ISO/ICH guidance/requirements pertaining to document content.

Interface with external regulatory groups (e.g., CRO, partners, consultants, etc.) in the preparation/review/compilation/finalization/submission/posting of regulatory submissions

Review and communicate current & emerging regulatory requirements (e.g., US and international regulations and guidelines)

Author and review standard operating procedures (SOPs); provide review that SOPs are in compliance with current regulatory requirements and support for corporate quality assurance efforts

Develop and maintain current regulatory knowledge

Coordinate with external API and critical material supply partners to manage regulatory submissions

Participate and support client quality audits and regulatory and health authority site inspections and pre-approval inspections of manufacturing facility and supporting systems.

What You'll Bring:

Bachelor's degree in a scientific discipline or equivalent. Advanced degree or Regulatory Affairs Certification is preferred.

Candidate must have at least 2 to 4 years of Regulatory experience in the pharmaceutical or biotechnology industry, with demonstrated increasing expertise and

Experience independently preparing and submitting documents in an eCTD compliant manner and assigning STFs preferred.

Must have a solid understanding of FDA regulations and ICH guidance, as well as a comprehension of the drug development process.

Experience with regulatory submissions in Common Technical Document format, is

Able to handle multiple projects and exercise good judgment in prioritizing

Demonstrated ability to work independently and within a group setting, and to interact effectively with various functional groups.

Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.

High level of attention to detail, and be proficient with Microsoft Office applications, Adobe, Sharepoint, and document management templates. Experience with eCTD publishing software is preferred.

For You To Know:

This position reports to the Manager of Regulatory Affairs or their designee

Travel on an intermittent basis is required (approximately 10-20%) to support job responsibilities and commitments.

This position works in a typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. This is largely a sedentary role; persons holding office positions are generally subject to inside environmental conditions having the lighting, temperature, and noise of an open floor-plan office environment. Regularly operate a computer and other office equipment. Regularly communicate with others in person, over the phone, and electronically. Must be able to move and/or carry objects weighing up to 10 lbs.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Life at Forge

We are a team of diverse, driven and passionate people working together to trailblaze a new model for how we make medicines to treat patients with genetic diseases. Our team members use their creativity and talent to invent new solutions, meet new demands, and offer the most effective services in the industry. Forge's core values lay the foundation for H.O.P.E. It provides us a common purpose that we all understand, work towards and live by.

HARDWORKING - We work hard and smart, making a persistent and determined effort toward success. Working hard, with focus and desire is the key.

OPEN - We strive to be approachable, actively listen and encourage others to contribute and speak up. We positively offer and receive constructive feedback.

PURPOSE DRIVEN - We are passionate about working towards and delivering on our mission to manufacture gene therapies.

ENGAGED - We are fully absorbed by and enthusiastic about our work and take positive action to further Forge's vision, mission and goals.

We've Got You Covered

We take the health and happiness of our employees seriously and are consistently evaluating new ways to make our benefits truly UnFORGEttable.

Health, Dental, and Vision insurance that starts on your first day at Forge, with 90% of premiums covered for team members as well as dependents

Competitive paid time off plan

Annual bonus for all full-time employees

401(K) company match

Fully-stocked kitchen with free food/drinks

12 weeks of paid parental leave - additional discount programs include childcare support & dependent care

Employee Assistance Program

Wellness benefits (financial planning services, mental health counseling, employer paid disability)

Onsite fitness facility

Professional & Personal development resources

Full-time