Senior Regulatory Affairs Specialist

Job Description:

We are actively seeking qualified candidates to join our talent pipeline for future client engagements, pending contract approval.  The Senior Regulatory Affairs Specialist, CMC is responsible for providing regulatory CMC support through the product life cycle. These job responsibilities include but are not limited to regulatory strategies, submission timeline development, change control, and preparing submission documents.

WORK LOCATION:

The Senior Regulatory Affairs Specialist, CMC position is eligible for remote work based on company requirements, with no minimum in-office requirement.

JOB FUNCTIONS:

(This list is not exhaustive and may be supplemented and changed as necessary.)

• Author and review high-quality, compliant CMC regulatory documents (e.g., Core Dossiers, INDs, CTAs, MAAs, BLAs, Variations and other relevant regulatory CMC filings) and support client in responding to health authority questions within defined timelines.
• Perform assessment of CMC changes, identifying global regulatory requirements, and evaluating supporting documentation to assess acceptability and identify potential risks.
• Assesses currently registered content, proposed changes, and justification for changes by utilizing client’s change control system during pre-submission planning.
• Responsible for regulatory operational activities including organizing, tracking, and sending submissions to publishing team for US and other international markets.
• Compiles documentation for regulatory submission packages including license renewals, updates and market registration for review and submission to regulatory agencies.
• Liase with client and client partners to collect the needed sources; communicate any issues or risks proactively.
• Ensures compliance with FDA, EMA, and global regulatory requirements; assures the quality of the investigational and commercial drug substances and drug products.
• Perform technical review of certificate of analysis, analytical test methods, specification, product development reports, Master Batch Records (MBR), validation protocol/report, and stability protocol/report/data.
• Work within multiple regulatory systems and tools during end-to-end submission process.
• Maintains knowledge of current FDA, EU, global regulations, and guidance applicable to marketed products.
• Support and prepare other CMC ad-hoc requests as per client requests.

QUALIFICATIONS AND REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform essential duties.

Education: 

• A Bachelor’s degree in a health or life science discipline is required; Advanced degree is preferred.

Technical Experience:

• 5+ years of experience in the pharmaceutical industry in research, manufacturing, analytical, or quality.
• 2+ years of experience in Regulatory-CMC.
• Ability to read, analyze and interpret technical documents and health authority regulations.
• Demonstrated experience authoring CMC sections in Module 1, 2 and 3 sections of regulatory filings required.
• Familiar with Common Technical Document (CTD) formatting.
• Working knowledge of the US and European regulations and ICH guidance is preferred.
• Demonstrated experience using regulatory systems and tools (e.g., TrackWise and Veeva Vault are preferred.
• Strong computer proficiency in the use of the MS Office Suite (Word, Outlook, PowerPoint, and Excel).

Knowledge, Skills, and Abilities:

• Strong time management skills: ability to work under pressure in a fast-paced environment, to coordinate multiple tasks concurrently, adapt to changing priorities, and to meet deadlines.
• Ability to work independently with minimal supervision and problem solve proactively.
• Skilled communicator, both written and verbal, who is able to present ideas and critical information to clients and internal team members effectively.
• Strong organizational skills and attention to detail.
• Outstanding professional demeanor and discretion.
• Ability to work effectively within a team environment; strong collaborator and interpersonal skills.
• Flexible and available to work additional hours as required.

ESSENTIAL FUNCTIONS:

Physical Demands:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition and our culture with programs that support each of our reward pillars.  This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.