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Global Regulatory Affairs Lead, CMC, Raleigh (NC) - M

Employer
ClinChoice
Location
United States - Raleigh (NC)
Salary
Competitive
Start date
14 Nov 2019
Closing date
13 Dec 2019

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

Description:
Title: Global Regulatory Affairs Scientist - CMC

Location: Raleigh, NC

Schedule: Full-time

CROMSOURCE is looking for an experienced Global Regulatory Affairs Scientist to join one of our biotechnology partner companies in the US, based either in Raleigh, NC or Atlanta, GA. The Global Regulatory CMC Scientist will define the strategy, planning and preparation of CMC documentation sections for regulatory submissions from a global perspective, while providing leadership on the cross-functional sub-teams.

Substantial experience with Biologics and/or Small Molecules is required for this role.

This opportunity is open to both employees and freelance applicants.

The successful candidate will be working on studies dedicated to one client . We are looking for someone with strong project management skills with Phase I studies, who is able to act quickly, make well considered decisions and provide solutions.

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your TalentSource Line Manager who will work closely with you to support your professional development and growth.

Main Responsibilities and Accountabilities:
  • Responsible for the strategy, planning, definition of content, preparation/writing, review and approval of global regulatory CMC submissions for assigned projects/products to achieve timely approvals to meet business needs.
  • Ensure the global regulatory strategy for assigned projects/products is consistent with the departmental and wider business missions, goals and objectives and meet the Health Authorities requirements.
  • Identify the necessary supporting CMC documents for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
  • Write, review and approve CMC sections for submissions (for example, for briefing documents, clinical trial applications, registrations, post-approval submissions, PIPs) and responses to Health Authority questions in line with agreed global regulatory strategy and within agreed timelines.
  • Effectively communicate the CMC regulatory strategy, risks and overall plans to the department and other closely linked business units.
  • Highlight and proactively communicates anticipated and on-going critical issues throughout the product life-cycle in a timely manner to key stakeholders.
  • Lead the preparation of the CMC SWOT analysis or regulatory risk capture document and coordinate the associated CMC challenge session.
  • Cross-functionally communicates CMC lessons learned from major submissions.
  • Main point of contact for all CMC related Health Authority interactions, including negotiation and satisfactory resolution of CMC issues to facilitate CMC approvals in all regions.
  • Lead cross-functional teams responsible for the preparation of responses to the Health Authority CMC questions for assigned projects/products.
  • Accountable for coordinating and overall approval of regulatory assessments for CMC changes and creation of entries and updates in the designated systems within defined timelines.
  • Responsible for the Regulatory CMC Scientist role and functions on a regional basis.
  • Leads initiatives and cross-functional work streams as required.
  • Provides input to external industry organisations on CMC matters.
  • Participates in recruitment, skill development and coaching of team members.
  • Responsible for management, coaching and development of direct reports, as required


Education, Qualifications & Experience:
  • Bachelor's Degree in Life Sciences or equivalent. Master's or PhD is preferred.
  • Extensive level of relevant experience in the pharmaceutical industry or a regulatory authority in a CMC review capacity.
  • Must have proven experience in a Regulatory Affairs CMC Biotech function as well as experience in pharmaceutical manufacturing, analytical development, process development and quality assurance/control or related technical field.
  • Proven track record of successfully authoring and contribution to delivering CMC sections of marketing authorisations for new biological and/or chemical entities
  • Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and post-approval products.
  • Experience of direct communication and negotiation with regulatory agencies on CMC matters
  • Experience participating in regulatory agency meetings on CMC matters
  • Experience with people management and development
  • Proven experience leading global diverse teams, meetings and discussions to deliver CMC sections of regulatory submissions for development and post-approval products


Skills & Knowledge:
  • Ability to contribute to globally diverse teams, meetings and discussions to deliver CMC sections of regulatory submissions for development and post-approval products
  • Global mind-set when defining regional CMC regulatory strategies and able to plan/coordinate delivery of related tasks and objectives
  • Experience negotiating and influencing others to deliver strategic business and CMC priorities in assigned regions
  • Knowledge of GMP requirements and standard systems (e.g. change management systems and tools)
  • Effectively works to build relationships and collaborate with people and teams
  • Ability to overcome obstacles, drive execution and deliver timely results for products in assigned regions and for departmental projects
  • Excellent communication skills, both verbally and in writing in an open, honest and constructive manner while actively listening and empathizing with others.
  • Ability to work cross-functionally, in a matrix organisation structure
  • Can define regional CMC regulatory strategies with a global mind set, in addition to planning and coordinating the delivery of related tasks and objectives.
  • Able to overcome obstacles, drive execution and deliver timely results for products in assigned regions and for departmental projects.
  • Demonstrates ability to inspire, motivate, drive performance and results and identify and develop potential in direct reports with diverse styles, cultures and beliefs.
  • Exceptional problem solving skills


If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001998

If you would like to discuss the role before applying through the website, please contact holly.price@cromsource.com for more information.

Why TalentSource Life Sciences/CROMSOURCE?

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

CROMSOURCE is an independent, international Contract Research Organization (CRO) operating in over 40 Countries and 16 offices with approximately 500 professional team members, making it one of the largest independent CROs in Europe. Our international headquarters location is in Verona Italy and Waltham, USA and with local offices in Belgium, The Netherlands, Germany, Poland, Russia, Spain, Switzerland and the United Kingdom.

Our key approach is to equally value our clients and our own people. Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel through our dedicated training team, focused on employee development. We also understand the importance of a good work-life balance and we offer flexible solutions for a high number of positions.

The success of these core values are evidenced by our below industry average turnover rates.

By joining our teams, you can be part of making a difference in the lives of people and experience a fulfilling and regarding career. Together, we help our clients succeed in their work developing medicines and medical devices for patients around the world.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

How can we help you on your next career move? Learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

Keywords: Regulatory Affairs, Reg Affairs, Scientist, Regulatory Scientist, Regulatory Associate, CMC, CMC Manager, Regulatory Manager, Regulatory Lead, CMC Lead, Chemistry Manufacturing Control, Regulatory Specialist, Biotech, Biotechnology, RA, Contract Research Organisation, CRO, Outsourced

Skills: Chemistry, Manufacturing & Control Lead, CMC Manager, Regulatory Affairs Associate, Scientist, CMC, Regulatory Location: United States - Raleigh (NC) Share:

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Company

ClinChoice

ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.

 

We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

 

Company info
Website
Telephone
+44 1628 566121
Location
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom

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