CMC Regulatory Affairs Manager/Associate Director (Biologics)
Are you looking to lead CMC regulatory activities in the post approval space for Biopharm products?
As a Regulatory Manager, you will Lead CMC regulatory activities in the late development and /or lifecycle management of GSK products.
Drives the CMC strategy, coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards, and taking into account the evolving regulatory requirements. Identifies risks to the business associated with submission data and information packages and provides and communicates well defined risk mitigation strategies. Mentors or trains staff. May have direct line management responsibility. Manages project activities for multiple complex projects and teams simultaneously, including those for reporting staff as appropriate. Provides strategic direction, data assessment and conclusions within and across departments. Able to establish organisational networks (internal and external) understanding departmental constraints/pressure within a highly complex organisation. . Engages and may lead CMC Subject Matter Expert activities, both internally (for increased compliance, harmonisation and efficiency) and externally (external advocacy and shaping the regulatory environment). 4. May deliver CMC regulatory strategy to support major inspections (eg PAI's) or quality incidents (PIRCs). 5. Has accountability for submission content. Understands, interprets and advises on regulations, guidelines, procedures and policies relating to development, registration and manufacturing of biopharmaceutical products, to expedite submission, review and approval of global CMC applications. 6. Ensures all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply. Ensures information submitted lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions. 7. Formulates novel approaches and influences people, evaluating/improving CMC Regulatory processes, policies and systems to enhance the efficiency and quality of departmental work.8. Directs and communicates complex regulatory issues independently across the company and with external agencies and third parties as necessary, to influence project and policy issues that are aligned with business needs ensuring optimum position for the company. 9. Operates with considerable independence, except for matters that affect corporate or agency policies. Rapidly and appropriately communicates sensitive matters or those with potential for high business impact. 10. May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.
B.Sc. in Life Sciences or related scientific disciplines
Three years or more years of experience in drug development and manufacturing and supply processes and may have a specialized area of expertise.
Three or more years complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
Three or more years of project management experience.
Three or more years of experience in major post approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management).
PhD in Life Sciences or related scientific disciplines
Ability to manage and direct multiple projects/teams
Track record of effective influencing and negotiating with regulatory agencies, industry bodies, and internal colleagues personnel in a variety of settings.
Demonstrated ability to handle complex global CMC issues through continuous change and improvement.
Ensure a good understanding of the science behind physical product manufacture, and the associated regulatory challenges with maintaining a compliant supply chain.
Life cycle management experience ideally including previous roles within pharmaceutical and/or vaccines marketed product support.
Significant experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs and with demonstrated experience of team leadership.
Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has identified opportunities to further educate internal colleagues and formulate approaches to most effectively meet new requirements.
Identified as CMC Regulatory expert in a specific subject area.
Highly developed interpersonal, presentation and communication skills with established internal and external networks.
Proven experience in supervising and training junior staff within an organisation and has the ability to motivate and lead others.
Detailed knowledge of drug development and manufacturing and supply processes and may have a specialized area of expertise.
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we’re making the biggest changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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