AbbVie

Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC)

AbbVie • $100K — $130K *
North Chicago, IL 60064In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
3 weeks ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering, or related subject required.
  • Advanced degree preferred; certification is a plus.
  • 6 years of experience in biopharmaceutical or related industry required.
  • At least 3 years of experience in regulatory affairs preferred.
  • Experience in complex, matrix environments is essential.
  • Strong oral and written communication skills are crucial.

Responsibilities

  • Prepare CMC regulatory product strategies under limited supervision.
  • Conduct analysis and interpretation of information impacting regulatory decisions.
  • Review and revise regulatory submission documentation for clarity and effectiveness.
  • Respond to global regulatory information requests as needed.
  • Develop strategies for CMC-related agency interactions and manage agency meeting requests.
  • Manage products, change control, and analyze manufacturing change records under supervision.
  • Represent CMC regulatory affairs on cross-functional teams to enhance submission approval success.

Benefits

  • Comprehensive benefits package including paid time off (vacation, holidays, sick).
  • Medical, dental, and vision insurance.
  • Participation in 401(k) plan for eligible employees.
  • Opportunity to participate in long-term incentive programs.
Full Job Description
Job Description

The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) - Biologics Product Lead, works with internal and external partners in order to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals under limited management supervision. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new market applications and supplements/variations with limited management supervision. Builds and maintain relationships within the Regulatory Affairs functional areas and the Operations and Research & Development (R&D) organizations. Represents RA CMC on product development and life-cycle management teams to negotiate, influence, and provide strategic advice to peers in RA, R&D, and Operations.

Responsibilities:
  • Prepares CMC regulatory product strategies with limited supervision. Prepares regulatory submissions, including new IND/CTA applications and amendments, renewals, annual reports, supplements and variations under limited supervision.
  • Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions
  • Reviews and revises regulatory submission documentation to effectively present data and strategy to regulatory agencies under limited supervision
  • Responds to global regulatory information requests under limited supervision.
  • Develop strategies for CMC-related agency interactions and manage preparation of agency meeting requests and information packages, under limited supervision
  • Manage products and change control with an understanding of regulations, agency guidance and company policies and procedures with limited supervision. Analyzes and approves manufacturing change records with limited supervision.
  • Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations Product Teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions and stays abreast of regulatory procedures and changes in the external regulatory environment.
  • Analyzes legislation, regulation and guidance and provides analysis to the organization under limited supervision
  • Contributes to creation of white papers and policies to illustrate current regulatory thinking under supervision of manager. Participates in initiatives internal to RA CMC
  • May act as a formal or informal mentor to others.
  • This position will work a hybrid work schedule (3 days in office) from the AbbVie Lake County, IL; Irvine, CA or Waltham, MA headquarters.

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

Qualifications
  • Required Education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
  • Preferred Education: Relevant advanced degree preferred. Certification a plus.
  • Required Experience: 6 years' biopharmaceutical or related industry experience.
  • Preferred Experience: 6 years biopharmaceutical RA, R&D or Operations experience including 3 years in regulatory affairs
  • Experience working in a complex and matrix environment
  • Strong oral and written communication skills


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 long-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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