AbbVie

Senior Associate, Regulatory Affairs - Chemistry, Manufacturing & Control (CMC) - Hybrid

AbbVie • $95K — $115K *
North Chicago, IL 60064Hybrid
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • BA/BS in Chemical or Biological Sciences or relevant discipline
  • 4 years pharmaceutical or related industry experience, with 1-2 years in quality systems or project management
  • Preferred: 5 years pharmaceutical experience including 1-2 years in regulatory affairs
  • Strong knowledge of manufacturing unit operations or CTD structure
  • Excellent oral and written communication skills
  • Experience with electronic document management systems
  • Ability to manage multiple projects under pressure and work independently
  • Detail-oriented and collaborative with a willingness to learn
  • Familiarity with US and international regulatory requirements for drug product dossiers

Responsibilities

  • Manage and author CMC sections of marketed product variations with minimal oversight
  • Collaborate with RA CMC Project Leads to develop content plans and project timelines
  • Engage with various functional groups to ensure compliance of CMC submissions
  • Ensure accuracy and thoroughness of CMC dossiers and manage team reviews
  • Monitor compliance with CTD formatting and structural requirements
  • Implement best practices for regulatory business systems
  • Communicate content gaps and risks identified to RA CMC Project Leads
  • Provide guidance on submission document templates
  • Support preparation of annual reports and renewals

Benefits

  • Paid time off (vacation, holidays, sick)
  • Medical, dental, and vision insurance
  • 401(k) plan for eligible employees
  • Participation in short-term incentive programs
  • Hybrid work schedule available (3 days in-office, 2 days remote)
Full Job Description
Job Description

The Senior Associate, RA CMC is responsible for ensuring RA-CMC post approval change objectives are met by project managing marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. The Senior Associate will also ensure proper communication with all key partners in the functional departments in support of regulatory filings.

Responsibilities:
  • Manage, compile, and author CMC sections of marketed product variations with minimal management oversight. Update simple CMC documents independently.
  • Partner with RA CMC Project Leads to create and develop content plans, bundling strategies, and project timelines.
  • Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
  • Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Independently run team review and management reviews of submission documents.
  • Ensure CMC expectations including CTD content, structural and formatting requirements are being met for assigned projects.
  • Provide input into and utilize current best practices for use of regulatory business systems within the group.
  • Timely communication of systems issues to management.
  • Communicate content gaps and risks for variation documents identified by RA CMC Project Leads.
  • Provide guidance on use of submission document templates.
  • Support annual reports and renewals (ad hoc baseline support)
  • This role works a hybrid work schedule (3 days in office & 2 days remotely) from the Lake County, IL; Waltham, MA or Irvine, CA AbbVie headquarters.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications
  • Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
  • Required Experience: 4 years pharmaceutical or industry related experience. 1-2 years in quality systems or cross functional project management
  • Preferred Experience: 5 years pharmaceutical experience including 1-2 years in regulatory affairs or 1-2 years in Discovery, R&D, or Manufacturing
  • Strong working knowledge of manufacturing unit operations or CTD structure
  • Superior oral and written communication skills
  • Ability to work cooperatively with all levels and types of global personnel required
  • Experience working with electronic document management systems
  • Ability to work independently under pressure and manage multiple projects simultaneously
  • Detail/accuracy oriented
  • Collaborative and willing to learn
  • Familiarity with US and other international regulatory requirements for drug product dossiers


Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
  • The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
  • This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

Explore Job Opportunities

AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

Join Our Team

Search open positions that match your skills and interests. We are looking for passionate, curious, and innovative team players who are ready to make a difference.

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Explore AbbVie Jobs

Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ
ABBV
* Ladders Estimates

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