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 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.
- 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.
- 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
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