Scientific & Regulatory Affairs Manager

Our team members are at the heart of everything we do. At Cencora we are united in our responsibility to create healthier futures and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval of the market development and any action of effective product maintenance. The success of our company resides in the expert knowledge and high motivation of our employees. Working for Pharmalex means being creative and adaptive. Our culture of continuous learning and commitment to diversity and inclusion creates an environment that allows you to build your skills and career.

Purpose

• Lead and support CMC biologics activities for PharmaLex projects as part of a global team.
• Provide a broad range of regulatory affairs support..
• Proactively support clients to deliver quality reg CMC work.
• Provide a wide range of flexible regulatory affairs services for different clients on a range of product types and therapeutic areas.
• Provide leadership and knowledge-based support for biologics CMC activities (e.g. compilation and review; gap analysis; CMC strategies; comparability exercises)
• Provide project management for regulatory activities
• Manage clients and other stakeholders
• Support business development; provide input into client proposals
• Provide critical technical review of documentation based on established experience
• Provide effective consulting support for CMC biologics

Experience and skills

• Established experience in regulatory affairs activities including :
• Module 3 IND / IMPD authoring and review
• MAA / BLA gap analysis
• Development of regulatory strategy
• Scientific advice procedures
• Submission management
• Experience with different territories authorization procedures and health authorities
• Experience with development and life-cycle management products
• Experience in biologics e.g. regulatory affairs manufacturing quality systems process analytical
• Established experience with a wide range of biotech product types including : ATMPs vaccines recombinant proteins plasma products and biosimilars.
• Focused and able to deliver high-quality work.
• Ability to work in a team.
• Strong sense of responsibility.
• Excellent written and verbal communication skills with a particular focus on client-facing interactions.
• Educated to at least a relevant science degree level preferably with a higher degree in a pharmaceutical discipline.
• At least seven years of experience in the biotech industry.

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Full time

Affiliated Companies

Affiliated Companies : PharmaLex Spain S.L.U.

Cencora is committed to providing equal employment opportunity without regard to race color religion sex sexual orientation gender identity genetic information national origin age disability veteran status or membership in any other class protected by federal state or local law.

The companys continued success depends on the full and effective utilization of qualified individuals. Therefore harassment is prohibited and all matters related to recruiting training compensation benefits promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Required Experience :

Manager

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1