Director Regulatory Affairs Global CMC

1100 Mylan Pharmaceuticals Inc.; Dublin; On-site; EUR 100,000 - 130,000; Full time

Benefits offered by this job

Excellent career progression opportunities

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Job summary

A global pharmaceutical company in Dublin is seeking a Director of Regulatory Affairs to develop strategic CMC regulatory approaches. The ideal candidate will have extensive CMC authoring experience, strong leadership skills, and in-depth knowledge of regulatory requirements. This role involves cultivating relationships with stakeholders, ensuring compliance with regulations, and managing cross-functional project teams. A competitive salary, bonus scheme, health insurance, and opportunities for professional growth are included.

Qualifications

• Extensive hands-on CMC authoring experience for regulatory submissions.
• Experience leading and managing technical teams and complex projects.
• In-depth knowledge of regulatory requirements across global markets.

Responsibilities

• Develop and implement CMC regulatory strategies for drug submissions.
• Establish relationships with regulatory agencies to ensure compliance.
• Lead cross-functional teams and manage resources and budgets.

Skills

CMC authoring experience

People and project management experience

Knowledge of cGMP

Regulatory negotiation skills

Education

Relevant degree in life sciences or related field

Job description

**Cookie Notice**McDermott Laboratories LimitedAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines regardless of geography or circumstance; Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and Partnership – Leveraging our collective expertise to connect people to products and services. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.**The Role & What You Will Be Doing**The Director, Regulatory Affairs CMC, is an emerging senior level position, recognized as an expert for global CMC regulatory knowledge and quality expertise. The position is primarily devoted to the independent development of strategic CMC regulatory approaches to expedite the preparation and review of regulatory submissions in support of the L-Upjohn product portfolio.Every day, we rise to the challenge to make a difference and here’s how the **Director, Regulatory Affairs Global CMC** role will make an impact:* Cultivates sustainable & effective relationships across a network of stakeholders, partners and customers to drive and establish aligned approaches to regulatory strategies and/or policies.* Interprets CMC regulatory requirements, develops strategies (including novel approaches), assesses risks and develops contingency proposals.* Uses technical and scientific knowledge in the preparation and analysis of global CMC submission documentation and maintenance of product compliance and management of CMC change control.* Ensures all CMC regulatory activities are executed effectively & efficiently, and in compliance with external regulatory requirements & internal quality procedures.* Serves as a liaison with regulatory agencies for specific topics and providing oversight for the fulfillment of agency commitments and providing responses to agency queries.* Presents and articulates issues for resolution, communicating regularly with key stakeholders to ensure alignment, providing consultation as a scientific/technical resource within the department/cross-functional and therapeutic teams for assigned projects, mentoring and sharing experience with colleagues.* Manages, leads and contributes significantly to Upjohn projects and initiatives within cross-functional project teams.* Executes training related activities (e.g. compliance-related, HR policies) & individual development plans, participates in cross-disciplinary forums and learning opportunities, engages in Straight Talk & Listen exchanges, demonstrates and models adherence to all Viatris’ behaviors & values, embraces & complies with Principles of Integrity.* Participates, as required, in pharmaceutical industry conferences or serves externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions.* Manages CMC responses in response to MedInfo queries* Serves on governance & steering committees and may serve as the global CMC lead in Due Diligence exercisesServing as a People Manager:* Provides guidance & direction to direct reports, managing resources, resource capacity & budget along with prioritizing workload appropriately.* Accomplishes performance-management & training related activities, encourages & supports a healthy work/life balance, supports roll-out of HR policies, takes hiring-related decisions, participates in succession planning, provides guidance & facilitates opportunities for talent development, encourages colleague participation in cross-disciplinary forums & learning opportunities, engages colleagues in Straight Talk & Listen exchanges, demonstrates & models adherence to all Viatris’ behaviors & values, embraces & complies with Principles of Integrity.* Serves as the primary reviewer of global CMC strategic plans and documentation/submissions**About Your Skills & Experience**For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:* Extensive years of mandatory hands-on CMC authoring experience (initial registrations or post-approval variations)* Extensive years of people and/or project management experience, serving as a leader of matrixed & technical teams* High level of knowledge of development & commercial activities and cGMP’s to assess technical, scientific & regulatory merits of CMC information, commitments and data to lead teams and/or complex projects.* Extensive technical, functional, and industry knowledge in shaping project strategy, reducing regulatory burden & improving regulatory flexibility across global markets and diverse therapeutic areas. Independently capable of executing activities related to complex projects across all aspects of drug development and commercial manufacturing product lifecycle.* Advanced understanding of current and emerging regulatory requirements & expectations, criteria for submission & approval globally, & experience in leading negotiations and interactions with regulatory authorities for projects and/or policy initiatives.* Possesses sound understanding of business expectations across partner lines, with proven ability to partner successfully with other Regulatory functions, Manufacturing & Supply Chain, Quality, Safety, Medical, Commercial, Legal and senior stakeholders to achieve objectives.At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.**Benefits at Viatris**At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:* Excellent career progression opportunities* Work-life balance initiatives* Bonus scheme* Health insurance* Pension**Diversity & Inclusion at Viatris**At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit**Sustainability at Viatris**Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visitAt Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Viatris is an Equal Opportunity Employer.