Job title:
Regulatory Affairs Manager (CMC)
Company:
Randstad
Job description
We are seeking a highly skilled Regulatory CMC Manager to play a vital role in shaping global regulatory strategies for innovative pharmaceutical products. In this position, you will lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and successful product development. This is a unique opportunity to contribute to global submission plans, refine regulatory strategies, and drive continuous improvement within a dynamic and forward-thinking environment.Regulatory Affairs Manager (CMC) Nr ref.: 378/1/2025/PT/259276/jobs.pl Warszawa (mazowieckie)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.
Your tasks
- Participates as the Regulatory CMC Lead on CMC/VST Teams and represents Global CMC Regulatory Affairs by providing regulatory expertise and input to team recommendations to facilitate successful product development globally.
- Actively participates on Global Regulatory Team(s) to 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.
- Develop and get buy-in on regulatory CMC strategy for Health Authority responses as needed.
- May participate in selected initiatives within CMC RA / GRA.
- Participates in and conducts due diligence/licensing evaluations as needed.
- Drives a culture of continuous improvement and communicates critical issues.
- 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 with 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; maintain good rapport and credibility.
- 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 8+ 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 interacting with Health Authorities under supervision of a senior member of the CMC RA staff.
- Good knowledge of global HA laws, regulations, guidance and regulation submission routes available for assigned products.
- Some understanding of competitors in the area and what they are doing in early/late development
Employment agency entry number 47this job offer is intended for people over 18 years of age
Expected salary
Location
Warszawa, mazowieckie
Job date
Tue, 01 Apr 2025 22:29:02 GMT
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