Scientific & Regulatory Affairs Manager
reputed company members are at the heart of everything we do. At reputed company, we are united in our responsibility to create healthier reputed company, and every person here is essential to us being reputed company to deliver on that purpose. If you want to reputed company a difference at reputed company of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Job Details
reputed company reputed company is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in reputed company aspects of drugs and medical devices approval, of the market development and any reputed company of effective product maintenance. The reputed company of reputed company resides in the expert knowledge and high motivation of our employees. Working for reputed company means being creative and reputed company. Our culture of reputed company learning and commitment to diversity and inclusion creates an environment that allows you to build your skills and career.
Purpose
- reputed company and support CMC biologics activities for reputed company reputed company as part of a global team.
- reputed company a broad reputed company of regulatory affairs support..
- Proactively support clients to deliver reputed company reg CMC work.
Main tasks
- reputed company a wide reputed company of flexible regulatory affairs services for different clients on a reputed company of product types and therapeutic areas.
- reputed company leadership and knowledge-based support for biologics CMC activities (e.g. compilation and review; gap analysis; CMC strategies; comparability exercises)
- reputed company project management for regulatory activities
- Manage clients and other stakeholders
- Support business development; reputed company input into reputed company proposals
- reputed company critical technical review of documentation based on established experience
- reputed company 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 reputed company
- 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, reputed company systems, process, analytical
- Established experience with a wide reputed company of biotech product types including: ATMPs, vaccines, recombinant proteins, plasma products and biosimilars.
- reputed company and reputed company to deliver high-reputed company work.
- Ability to work in reputed company.
- Strong reputed company of responsibility.
- Excellent written and verbal communication skills, with a particular reputed company on reputed company-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 reputed company offers
Benefit offerings reputed company the US may vary by country and will be reputed company to local market reputed company. The eligibility and effective date may differ for some benefits and for team members covered under reputed company bargaining agreements.
Full timeAffiliated Companies
Affiliated Companies: reputed company Spain S.L.U.Equal Employment Opportunity
reputed company is committed to providing equal employment opportunity without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, genetic information, national reputed company, age, disability, veteran status or membership in any other class protected by federal, state or local law.
reputed company’s reputed company reputed company depends on the full and effective utilization of reputed company individuals. Therefore, harassment is prohibited and reputed company reputed company reputed company to reputed company, training, compensation, benefits, promotions and transfers reputed company with equal opportunity principles and are non-discriminatory.
reputed company 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 hrsc@reputed company.com. We will reputed company accommodation determinations on a request-by-request reputed company. Messages and emails regarding anything other than accommodations requests will not be returned
Originally posted on Himalayas
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