Informacje o stanowisku

Join one of the largest pharmaceutical companies worldwide as a Regulatory Affairs Director (CMC) and play a pivotal role in shaping the future of global regulatory strategies for pharmaceutical products. This is an exciting opportunity to lead high-performing teams, drive strategic initiatives, and collaborate with global leaders to ensure compliance, innovation, and excellence throughout the product lifecycle.

What we expect

• BS in biological, pharmaceutical, chemical or engineering sciences with generally a minimum of 12+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent.
• Proficiency in English (min. C1).
• Successful experience in leading a diverse community of professionals in a global and matrix environment. Seasoned leader, decision maker and constructive challenger.
• Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry.
• Proven track record and/or deep understanding in developing and implementing successful CMC regulatory lifecycle strategies and seen as an expert on product development and how it is applied to global regulatory strategy.
• Strong attention to detail with high-level verbal and written communication skills.
• Makes decisions based on facts and sound scientific principles.
• Ability to interact with all levels in the organization.
• Communicates cross-functionally and cross-company; presents and defends CMC management-approved regulatory strategy to project teams; recognizes and accounts for global regulatory impact.
• Demonstrates model behavior that understands what the priorities are and encourages others to drive for results.
• Experience leading health authority interactions.
• Strong knowledge of global regulatory laws, regulations, guidance and submission routes pertaining to drugs from early development to commercial maturity.
• 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

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

• Work closely with the senior leadership team in developing and proposing direction in key areas to ensure a high performing organization and consistent application of practices, policies, systems and programs.
• Planning, organizing, and directing resources and activities within CMC RA. Drive the execution of identified projects and workstream.
• Lead selected initiatives within CMC RA / GRA.
• Supervise and provide leadership and oversight for the CMC RA teams that develop and execute global CMC regulatory strategy for one or more product(s).
• Responsible for talent and development management strategy in line with the GRA strategy within his/her group.
• Identify, prioritize and drive projects and workstreams. Assures that appropriate objectives and metrics are established, monitored and met, including removing barriers.
• Participates in and conducts due diligence/licensing evaluations as needed.
• Responsible for training, coaching and development of the team members.
• Drives a culture of continuous improvement and communicates critical issues to Senior Management.
• Represents CMC RA on business meetings.
• Serves as a SPOC/SME on internal and external teams to proactively influence policy and practice on specific areas of CMC regulatory expertise.
• Creates engagement and a culture of collaboration flexibility, and competitiveness by increasing business and scientific acumen, industry knowledge and skills.
• Enables a culture of performance driving a more flexible organization using levels as process improvement and innovation supported by the business support group.
• Support the senior leadership in driving implementation of strategic plans.
• Support team to ensure the CMC development and commercial product regulatory strategy meets global regulatory requirements.
• Develop and update contingency plans for issues that may affect registration, regulatory compliance and the continued lifecycle management of the products in scope. Escalates critical issues.
• Effectively and tactfully communicates with health authorities.
• Reviews and approves CMC regulatory dossiers for global submissions throughout the product lifecycle.

Warszawa - Oferty pracy w okolicznych lokalizacjach