Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries.
Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide.
The company has sites/offices in China, US, EU and Asia.
The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies.
Job description: Regulatory Affairs Director Reporting to the Global Head of the Regulatory Affairs (RA), the RA Director will play a pivotal role in ensuring the highest standards of professional excellence, regulatory adherence and quality within the business.
With overall responsibility for the management of RA projects at WuXi Biologics Ireland, leading and organizing the regulatory procedures in Ireland, following up on the legislation requirements and communicating with the relevant stakeholders.
Department Description: As Regulatory Affairs Director, youll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives.
In this role you will report to the EU/US Lead.
Your Responsibilities: Serve as the Regulatory CMC lead for internal and external project teams, acting as the primary point of contact for all critical regulatory matters.
Manage a team of Regulatory Affairs professionals, including direct reports and SMEs of sub-teams.
Lead interactions and formal communications with governmental agencies (e.g., EMA, HPRA, FDA) to support regulatory submissions and negotiations.
Lead and coordinate Health Authority meetings and negotiations (e.g., scientific advice, pre-IND, pre-BLA/MAA), including development of briefing books, risk mitigation plans, and team rehearsals.
Participate in departmental budget and revenue planning, execution, and reporting.
Responsible for setting and tracking KPIs aligned to department and corporate goals.
Oversee a significant regulatory affairs portfolio that may include 30+ global projects with a cumulative value exceeding $10 million, ensuring strategic alignment and regulatory excellence across programs.
Drive RA developments, establishment, and improvement for Ireland and Germany sites.
Represent the company attending regional and global regulatory strategy forums and high-level external regulatory negotiations, partnerships, and trade associations.
Provide company-wide updates on regulatory trends, impact assessments, and draft guideline comment coordination through cross-functional engagement.
Actively influence and guide cross-functional project teams, ensuring alignment of regulatory goals with project milestones and commercial objectives.
to support integrated projects throughout the entire development lifecycle.
Develop and maintain professional partnerships with both internal and external stakeholders.
Drive the development of departmental regulatory strategy by anticipating emerging trends, conducting due diligence on new business opportunities, and providing strategic analysis from a regulatory perspective.
Collaborate closely with RA senior leadership to shape and refine the long-term strategic roadmap for Regulatory CMC.
Act as a role model for the RA function and the wider organization in adherence to the WuXi corporate core values, local site shared commitments/behaviors.
Your Profile: Qualifications: Masters degree in Science or related field required.
Experience with at least one major marketing application.
Knowledge/Experience/Technical Competencies: In-depth knowledge of evolving regulatory requirement trends and guidance.
Good understanding of complex biologics manufacturing science.
Familiarity with CMC terminologies.
Excellent project management skills including planning, organising and ability to motivate and lead others.
Minimum of 10 years pharmaceutical industry experience in R&D, Regulatory CMC, or related functions, with at least 5 years working in regulatory affairs CMC.
Extensive knowledge of regulatory requirements for biologics in the EU, and local regulatory requirements for drug manufacturing.
Strong technical aptitude (i.e.
able to read & comprehend technical documentation & execute procedures).
Strong knowledge of cGxP requirements and regulations.
Knowledge of trouble shooting and problem-solving skills, e.g.
formal root cause analysis such as Ishikawa diagrams, FMEA etc.
Behavioural Competencies: Excellent communication and interpersonal skills, with the ability to work collaboratively in cross-functional teams.
Excellent leadership skills.
Develops collaborative relationships with internal stakeholders and clients.
Proven ability to influence across functions without direct authority to deliver complex projects and regulatory filings successfully and on time.
Ability to think clearly and in a decisive manner; remain calm under adverse conditions.
Understands issues, problems, and opportunities with an open mind and critical thinking skills.
Demonstrated strength in strategic thinking, with the ability to make complex decisions and a willingness to manage challenging positions.
Ability to drive for business continuous improvement and customer focused.
Unquestionable ethics, professional integrity, and to demonstrate PROUD values consistent with WuXi Biologics.
Other Requirements Fluent in English and German is desired.
As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together.
If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our mission -Any drug can be made, and any disease can be treated - dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential.
Would you like to know more before you apply?
Please visit us ator contact us viaWuXi Biologics is an equal opportunities employer.
Skills: Leadership Quality Compliance Organisational Stakeholder Management Benefits: Bonus Parking Pension Sports & Social Club VHI