Step into a pivotal role as Manager, Regulatory Affairs and contribute to the global development and lifecycle management of groundbreaking pharmaceutical products. As a key member of team, you will lead the development and execution of global CMC regulatory strategies, ensure compliance with regulatory requirements, and represent Global CMC Regulatory Affairs in cross-functional and external collaborations. This is an exciting opportunity to shape global submission plans, drive continuous improvement, and influence policy and practices within a dynamic and innovative environment.
what we offer- hybrid model of work for flexibility and convenience,
- company car to support your mobility needs,
- comprehensive private medical care and life insurance for you and your family,
- a robust company pension plan to secure your future,
- reimbursement for sports activities and access to well-being programs to promote a healthy lifestyle,
- annual bonus recognizing your contributions and achievements,
- beneficial leave policies to support your personal and professional needs.
- providing regulatory expertise and input to team recommendations to facilitate successful product development globally;
- develop global submission plans that comply with local regulatory requirements and commitments;
- develop and execute global CMC regulatory strategy;
- leads the preparation of regulatory dossiers for submission to Health Authorities;
- may lead selected initiatives within CMC RA / GRA;
- participates in and conducts due diligence/licensing evaluations as needed
- may provide oversight of assigned staff;
- drives a culture of continuous improvement and communicates critical issues to management;
- may serve as a SME on internal and external teams to proactively influence policy and practice on specific areas of CMC regulatory expertise;
- ensures the CMC development and commercial product regulatory strategy meets global regulatory requirements;
- assures connectivity to the overall global regulatory strategy through partnership and communication other departments;
- refines regulatory strategies as new data become available.
- develop and update contingency plans for issues that may affect registration, regulatory compliance and the continued lifecycle management of the products in scope;
- effectively and tactfully communicates with health authorities;
- reviews CMC regulatory dossiers for global submissions throughout the product lifecycle
- provides accurate regulatory assessments of chemistry, manufacturing and control changes to teams/projects and executes regulatory planning and implementation.
what we expect
- BS in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 10+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent;
- proficiency in English (min. C1).
- demonstrated ability to communicate regulatory requirements;
- solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry;
- experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy;
- Strong attention to detail with high-level verbal and written communication skills;
- communicates cross-functionally and cross-company. Presents and defends CMC management-approved regulatory strategy and opinion to project teams;
- demonstrates model behavior that understands what the priorities are and encourages others to drive for results
- experience leading interactions with Health Authorities under supervision of a senior member of the CMC RA staff;
- strong knowledge of global HA laws, regulations, guidance and regulation submission routes available for assigned products.
- good understanding of competitors in the area and what they are doing in early/late development.
Employment agency entry number 47
this job offer is intended for people over 18 years of age
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