Senior Regulatory Affairs Specialist (pharma CMC)

Date: Feb 10, 2024

Location: Lakewood, CO, US

Company: Terumo BCT, Inc.

Requisition ID:  31510  

 

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

 

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.

 

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential. 

As a Senior Regulatory Affairs Specialist, you will primarily focus on the submission process for pharmaceutical CMC (Chemistry, Manufacturing, and Controls). As a key player in our regulatory affairs team, you will leverage your expertise to ensure the successful preparation and submission of CMC regulatory documents, collaborating closely with cross-functional teams and regulatory agencies. This role offers a unique opportunity to make a significant impact on the regulatory strategy and compliance of our cutting-edge products. If you thrive in a fast-paced, innovative environment and possess in-depth knowledge of regulatory guidelines, we invite you to apply and contribute to the advancement of healthcare through regulatory excellence. Join us in shaping the future!

 

ESSENTIAL DUTIES

  • Responsible for developing regulatory strategies and plans for new or modified product.
  • Identifies and defines contents for regulatory submissions/dossiers. Influences the testing strategy and test report contents. Supervise the assembly of the regulatory submissions. 
  • Write and prepare U.S. and international submissions for new products ensuring timely approval for market release.
  • Assess product design, manufacturing, packaging, sterilization, and labeling changes for compliance with applicable regulations and prepare submissions, as required, by geography. 
  • Maintain current and grow regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies. 
  • Represents regulatory on project teams to develop regulatory strategies, including reviewing the various specifications and testing plans/reports, keeping in mind defined target market.
  • Review product labeling and ensure compliance with applicable US and international regulations.
  • Negotiate and interact with and/or directs others in interacting with Regulatory Agencies and Certification authorities, during the development and review process to ensure submission approval
  • Identifies the need for, prepares, and conducts regulatory related training for the business. 
  • Reviews advertising and promotional materials for compliance with global regulations; analyses and recomends appropriate changes. 
  • Collaborates with individuals at different levels and develops or is responsible for the development of solutions to problems.
  • Makes recommendations for improvements within the organization.
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
  • Participate in preparation and execution of audit required to enable of maintain market access.
  • Identify the need for new or modified regulatory procedures, SOPs, and participates in development and implementation. 
  • Interpret the intent of regulations and policies and provide such information to project teams and management. Work with the TBCT organization to meet the requirements.
  • Develops and executes strategies for responses to FDA, Notified Body, and government agency questions with team.
  • Provide mentoring, training, and support to other members of the regulatory department.
  • Assist in regulatory due diligence for potential and new acquisitions.

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

Bachelor’s degree in physical/biological sciences or engineering preferred, or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered. Previous relevant experience and/or combined with a Masters in Regulatory Affairs may also be considered.

 

Experience

Seven (7) years' experience in Regulatory Affairs preferred or a mix of Regulatory and Quality experience in a regulated environment. Previous relevant experience and/or combined with a Masters in Regulatory Affairs may also be considered.

 

Skills

  • Must have excellent written and verbal communication skills. 
  • Must be self-motivated by working independently and having the ability to take ownership of her/his responsibilities.
  • Must be able to prioritize and handle several projects concurrently.
  • Must be able to provide leadership and mentoring skills and/or supervision to less experienced regulatory personnel.
  • Must be able to maintain confidentiality in dealing with regulatory and clinical documentation.
  • Must have authored a regulatory submission in the US, EU and/or Canada that was submitted for regulated agency review.
  • Must have in-depth working knowledge of U.S. and/or international medical device and/or pharmaceuticals and/or biologics regulations and standards and the ability to apply knowledge to submissions reviewed by a regulated agency.
  • Able to apply business insight and have ability to understand how product approval strategy interacts with business strategy.
  • Demonstrated ability to collaborate and think innovatively (outside the box).
  • Nimble learning and have ability to actively seek out relevant legislation and competitive information on product lines.
  • Apply previous regulatory experience to help ensure success of submissions.

Certificates, Licenses, Registrations

Regulatory Affairs Certification (RAC) preferred.

 

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

 

PHYSICAL REQUIREMENTS

Typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

 

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

 

Additional Physical Requirements

Some travel required (up to once a quarter).

 

 

Target Pay Range:  $114,000.00 to $125,000.00  -  Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base:  10.0%

 

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family. Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more. To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates. For us, it’s about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

 

  • Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
  • In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
  • We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
  • We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
  • Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
    • Respect – Appreciative of others
    • Integrity – Guided by our mission
    • Care – Empathetic to patients
    • Quality – Committed to excellence
    • Creativity – Striving for innovation
  • We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

 

We are proud to be an Equal Opportunity Affirmative Action Employer.  All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

 

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment. Our Colorado campus locations are tobacco-free workplaces, and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.


Nearest Major Market: Denver

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