Senior Manager - CMC Regulatory Affairs Biopharm Development Projects Job at GSK (Collegeville)

Job Description

This position is responsible for leading CMC regulatory activities for investigational, late development and/or early commercial GSK products.

Job Responsibility

Drives the CMC strategy coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development/registration/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)
May deliver CMC regulatory strategy to support major inspections (e.g. PAI's) or quality incidents (PIRCs)
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
Ensures all appropriate CMC regulatory aspects for clinical trials/product release are in place, to avoid clinical holds and/or to ensure continuity of market supply
Ensures information submitted in clinical/marketing applications/lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions
Formulates novel approaches and influences people, evaluating/improving CMC Regulatory processes, policies and systems to enhance the efficiency and quality of departmental work
Directs and communicates complex regulatory issues independently 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
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
May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.

Requirements

Bachelor's degree in Life Sciences or related field
Four or more years of experience in drug development and manufacturing and supply processes and may have a specialized area of expertise
Four or more years of experience interpreting and executing complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment
Two or more years of experience completing project management tasks.

Nice to have

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
Developing experience in major filing activities (MAA/NDA/BLA, significant manufacturing change or key development interactions at EOP2/pre-Phase 3 or other regulatory interactions in early development)
Development experience ideally including previous roles within pharmaceutical and/or vaccines product development
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
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.

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave

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Senior Manager - CMC Regulatory Affairs Biopharm Development Projects

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