Director, CMC Regulatory Affairs
The Director, CMC Regulatory Affairs, directs key, strategic CMC regulatory activities in the late development and /or lifecycle management of GSK biopharmaceutical products. This role will have management oversight for a team ensuring compliance with GSK policies and procedures, staff development and training to deliver roles.
This is a fully global role which collaborates with colleagues in all markets as well as at an array of stakeholders, both internal and external. This means you'll work with a diverse group of people, both functionally and culturally, developing a vast personal network as well as global capability. You will have a wide-ranging scope, alongside considerable responsibility and accountability for leading the direction of CMC strategy for his/her assigned product(s). This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Represents Global CMC Regulatory on Regulatory Networks and Matrix Teams providing and overseeing strategic direction and guidance to Supply Chain (PSC/GIO) , Quality Assurance, 3rd Party Contract Management, Commercial and wider GRA on both global project and key strategic business initiatives.
- Identifies key risks to the business associated with submission strategy and information packages and provides and communicates to senior management well defined risk mitigation strategies.
- Likely to have direct line management responsibility. Coaches and mentors staff across CMC RA on lifecycle management in CMC.
- Has effective organisational (internal and external) networks. Leads influences and motivates staff within and across departments.
- Commercially astute and organisationally aware and able to deal with sensitive and confidential issues. May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
- Delivers CMC regulatory strategy to support major inspections (eg PAI's) or quality incidents (LICs/PIRCs).
- Likely to be involved in and lead current, business critical activities across internal and external networks on behalf of the company. Leads the company position to influence the internal/external CMC Regulatory environment through specialist areas of intelligence.
- Has accountability for submission content. Understands, interprets and advises on regulations, guidelines, procedures, policies and strategies relating to development, registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications in alignment with regional requirements.
- Directs resources (across multiple projects and teams simultaneously) to ensure all appropriate CMC regulatory aspects to support license maintenance and change control requests including transfer of supply within the company or with a 3rd party are delivered to agreed timelines.
- Formulates novel approaches and influences people, evaluating/improving CMC Regulatory processes, policies and systems to enhance the efficiency and quality of departmental work.
- Operates with independence. Directs and communicates complex regulatory issues independently at senior levels across the company and with external agencies and third parties as necessary, to influence CMC project and policy issues that are aligned with business needs ensuring optimum position for the company.
- Responsible for managing budget and resource for their teams. Responsible for team compliance with GSK policies and procedures, staff development and training to deliver roles
This position requires technical knowledge, but also significant interpersonal and communication ability. We are looking for someone who can work effectively across boundaries - both cultural and functional. This international role requires partnership with other companies and countries, meaning a flexible communication style and astute cultural awareness are highly valued. You'll be a direct leader but also work in a matrix structure, so leadership capability is a must. As a senior contributor to the Bio Pharma Mature Products organisation, we need an agile, confident decision maker - someone able to solve sophisticated problems with effective solutions. Often you will be accountable for the delivery of these solutions, so project and resource management capability is also important in this role.
Please take a copy of the Job Description, as this will not be available post closure of the advert.Why You?Required Qualifications and experience:
Preferred Qualifications and experience:
- Degree - life sciences or related scientific discipline
- Able to demonstrate the following key high performance behaviors: customer driven, flexible thinking, and continuous improvement
- Detailed knowledge of drug development and manufacturing and supply processes and may have a specialized area of expertise.
- Detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
- 3-5 years experience in project management and multi-tasking skills.
- Influencing and negotiating with regulatory agencies, industry bodies, and personnel within the company in a variety of settings.
- Can handle complex global CMC issues through continuous change and improvement.
- 1-3 years experience in leading major post-approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management)
- Masters or PhD in life sciences or related scientific discipline
- Life cycle management experience ideally including previous roles within pharmaceutical and/or vaccines product support.
- Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
- Has identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements.
- Identified as CMC Regulatory expert in a specific subject area.
The Director, CMC Regulatory Affairs will be the representative to major governing bodies, providing advice and direction regarding regulatory requirements and strategies. Requires ability to assess and mitigate risk with relevant stakeholders across the CMC matrix. Operates routinely with senior level leaders within the organisation to set internal regulatory strategy to ensure alignment with the external guidance and legislation.Why GSK?
GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. This special purpose - along with our goal of being one of the world's most innovative, best performing and trusted healthcare companies - helps us attract some of the best and brightest minds in the world.
We take pride in providing access to all and continually focus on our opportunity and obligation to do more to improve inclusion and diversity: for our people inside GSK; in the way we do business; and in the communities where we operate.
We want our company to be a place where diversity of people and thought is valued everywhere and where we're all able to be ourselves and feel a sense of belonging. An inclusive organization where we all feel valued, engaged and supported, knowing that our work makes an important contribution to our mission.Reinforced by our clear values and expectations
, it is part of our DNA.
Together we achieve extraordinary things for our patients and consumers, who rely on us each and every day.
When applying for this role, please use the ‘cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
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