AbbVie

Director, RA CMC

AbbVie • $140K — $180K *
Waltham, MA 02453In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering, or related field required; advanced degree preferred.
  • 10 years of biopharmaceutical experience, with a minimum of 3 years in enterprise leadership.
  • At least 5 years of experience in Regulatory Affairs or relevant experience in regulatory activities.
  • Experience developing and implementing global regulatory strategies.
  • Capability to interface with government regulatory agencies effectively.
  • Demonstrated success in leading within a complex, matrixed environment.
  • Strong understanding of business operations and enterprise culture.
  • Excellent oral and written communication skills.

Responsibilities

  • Prepares and manages CMC regulatory product strategies and submissions, including INDs/CTAs and marketing applications.
  • Advises internal teams on effective regulatory strategies and provides expert technical support.
  • Reviews regulatory submission documentation for clarity and effectiveness in presenting data.
  • Develops strategies for agency interactions and leads preparations for agency meetings.
  • Manages product change control while ensuring compliance with relevant regulations and internal policies.
  • Represents RA CMC in cross-functional teams and influences decisions for first-pass approval of submissions.
  • Stays updated on regulatory changes and leads the development of organizational white papers.
  • Designs initiatives for business efficiency within regulatory operations.
  • Trains and mentors staff, with potential formal supervisory responsibilities.

Benefits

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

The Director I Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. Prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations. Builds and maintains 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 and management in RA, R&D, and Operations. Serves as strategic liaison with regulatory agencies (e.g., FDA) regarding CMC matters. May include formal supervisory responsibilities. Manages assigned projects within assigned resources.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.
  • Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions, including new IND/CTA applications and amendments, new marketing authorization submissions, renewals, annual reports, supplements and variations, and/or leads a global RA CMC team who develops strategies for development and marketed products
  • Advises internal personnel on regulatory strategies. Provides strategic regulatory advice to peers and management in RA, R&D, and Operations. Seeks internal and external expert advice and technical support when necessary.
  • Reviews and revises regulatory submission documentation to effectively present data and strategy to regulatory agencies. Devises regulatory strategies for complicated scenarios (e.g., complex dosage form or multiple operational changes, aggressive timelines).
  • Develops strategies for CMC-related agency interactions and manages preparation of agency meeting requests and information packages. Serves as the point of contact for the regulatory agency meetings and leads CMC discussion for projects with health authorities. Drives strategic change planning with Manufacturing Operations using a risk-based approach centered on assessment of potential impact to quality, safety or efficacy.
  • Manages products and change control in compliance with an understanding of regulations, guidances and company policies and procedures. Analyzes and approves manufacturing change records.
  • Represents RA CMC on teams such as the product development, Global Regulatory Product Teams and Operations Product Teams, for assigned projects; negotiates with and influences team members to maximize chances for first pass approval of regulatory submissions
  • Stays abreast of regulatory procedures and changes in external regulatory environment. Analyzes legislation, regulation and guidance and provides analysis to the organization. Leads creation of white papers and policies to illustrate current regulatory thinking.
  • Designs initiatives to drive business efficiencies across the organization (within or outside of the regulatory groups). Ensures enterprise culture initiatives are implemented across RA CMC.
  • Trains, develops and mentors individuals; may include formal supervisory responsibilities of product leads. Evaluates performance of and assists in career development planning for assigned staff.


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: 10 years biopharmaceutical experience with 3-plus years demonstrated enterprise leadership. 5-plus years in RA or relevant exposure to RA activities
  • Preferred Experience: 10-plus years biopharmaceutical RA, R&D, or Operations experience, including 7-plus years in regulatory affairs
  • Experience developing and implementing successful global regulatory strategies
  • Interfacing ability with government regulatory agencies
  • Success leading in a complex and matrix environment.
  • Strong understanding of the business/enterprise
  • 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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