Senior Regulatory Affairs Associate

Job Title: Sr Associate Regulatory Affairs – CMC

Location: Remote

Duration: 12 Months (Possibility of extension depending upon business requirements and performance)

Top 3 Must Have Skill Sets:

• General US regulatory experience, including US state license applications and submissions
• Experience with document management systems
• Experience with basic project management

Overview:

• The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development.
• Support may include organizing, managing and executing on regulatory CMC projects in support of regulatory submissions.
• Tasks may include formatting of documents per style guide, searching for and organizing data from regulatory repository systems, drafting meeting agendas and minutes, managing document reviews, and other tasks as requested.

What we are looking for:

• Strong organizational skills with attention to detail.
• Proficient time management skills and ability prioritize workload.
• Ability to work both independently and as a member of a team.
• Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project.
• Qualified to work in the U.S. without employer sponsorship.
• Commitment of a 40-hour work week in Thousand Oaks, California.

Basic Qualifications:

• Master's degree and 2 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience

OR

• Bachelor's degree and 4 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience

OR

• Associate degree and 6 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience

OR

• High school diploma/GED and 8 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical, and/or related scientific experience.

Preferred Qualifications:

• Degree in life sciences, biochemistry, or chemistry
• Experience in biopharmaceutical or pharmaceutical industry
• Familiarity with eCTD structure
• Motivated with initiative to learn quickly
• Experience in CMC, including preparation of submissions to Agencies
• Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project

Top 3 Must-Have Skill Sets:

• Can-do Attitude – Ideal candidate does not easily give up. The candidate will be provided direction and support but will need to be methodical and analytical when completing tasks while exhibiting a positive attitude (this is a very large organization and there will be many parties the candidate will need to engage with for project success).
• Being Comfortable with Being Uncomfortable – Ideal candidate will not only be able to identify problems but also identifies possible solutions. Project end goals will be known but all the in-between steps may not be known from the start so the candidate will need to navigate and structure the steps without being easily flustered.
• Attention to Detail – Ideal candidate will be thorough and deliver polished work product.

Daily Responsibilities:

• Will be focused on providing submission execution support to products across modalities, regions and phases of development
• Timely and accurate submission of license applications including:
• Monitoring state license renewal schedules,
• completing state license applications and renewal forms,
• liaising with licensing consultants,
• Working in client’s financial systems to request checks for state licensing fees.
• Entering licensing information and filing licensing documentation into the regulatory document management system,
• Maintaining and optimizing relevant databases, tracking systems and document management processes to support the licensure process.
• Additional responsibilities may include supporting and or leading specific regulatory projects.

Red Flags:

• Leaving assignments before projects are complete
• Unexplainable time gaps in resumes
• References that are not from recent employers
• References that are not direct supervisors

Interview Process:

• Phone screening of possible candidates.
• In-person interview for those who pass the phone screening.
• We can start interviewing immediately and will be available as needed.

Additional Onboarding Requirements:

• As this role is highly visible in nature, please send candidates that are personable and pleasant over the phone (e.g., you would hire them because they are a “people person”).

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com

Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.

California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.

LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $28.00/hr.