CMC Regulatory Affairs Leader
2 days ago
At 1925 GlaxoSmithKline LLC, we are committed to unifying science, technology, and talent to get ahead of disease together. As a global biopharma company, our purpose is to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns.
Job DescriptionWe are seeking an experienced CMC Regulatory Affairs professional to lead our efforts in lifecycle management for biopharmaceutical products. The ideal candidate will have a strong background in regulatory affairs, with expertise in post-approval filing activities, complex worldwide CMC regulatory requirements, and project management skills.
Key Responsibilities- Represent Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing strategic direction and guidance to Supply Chain, Quality Assurance, and Commercial teams.
- Identify key risks to the business associated with submission strategy and information packages, and develop well-defined risk mitigation strategies.
- Lead and manage cross-functional teams, ensuring compliance with GSK policies and procedures, staff development, and training to deliver roles.
- Manage budgets and resources for teams, and ensure effective organizational networks and leadership.
- Collaborate with senior management to influence the internal/external regulatory environment and drive business-critical activities.
$120,000 - $180,000 per year, depending on experience and location.
Required Skills and QualificationsThe successful candidate will have:
- BSc in Life Sciences or related scientific discipline with 5+ years of Post Approval CMC Regulatory experience for biopharmaceutical products.
- Experience leading major post-approval filing activities for biopharmaceutical products.
- Knowledge of biopharm drug development and manufacturing processes.
- Strong communication and influencing skills, with the ability to negotiate with regulatory agencies and industry bodies.
- Able to work independently and operate at a high level of autonomy.
As a member of our team, you can expect:
- A comprehensive benefits package, including medical, dental, and vision insurance.
- A retirement savings plan, with employer matching contributions.
- Generous paid time off, including vacation, sick leave, and holidays.
- Ongoing training and professional development opportunities.
At 1925 GlaxoSmithKline LLC, we offer a dynamic and supportive work environment that fosters innovation and collaboration. We are committed to diversity, equity, and inclusion, and strive to create a workplace where everyone feels valued, respected, and empowered to succeed.
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