Scientific & Regulatory Affairs Manager

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Job Details

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.

Main tasks

• 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

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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.

Affiliated Companies

Equal Employment Opportunity

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 company’s 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 [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Originally posted on Himalayas