Biopharm CMC Regulatory Project Manager
- Collegeville, PA
Site Name: UK - Hertfordshire - Ware, USA - Pennsylvania - Upper Providence
Posted Date: Mar 2 2020
Are you looking for a role where you can be responsible for the CMC regulatory activities of complex biopharmaceutical products across multiple global markets? If so, this is the job for you.
As a Regulatory Affairs Project Manager, you will represent Global CMC Regulatory on Regulatory Networks and Matrix Teams providing regulatory advice and guidance to Medicines Science & Technology, Pharma Supply Chain, Commercial teams, Quality Assurance, 3rd Party Contract Management and Regulatory to produce appropriate CMC components for global regulatory dossiers with appropriate guidance from supervisor, as necessary.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
- Understand and advise on regulations, guidelines, procedures and policies relating to development, registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global CMC applications.
- Ensure all appropriate CMC regulatory aspects for clinical trials, product release and stability are in place, to avoid clinical holds, and to ensure continuity of market supply.
- Ensure information submitted in marketing applications meets regional requirements, allowing maximum manufacturing flexibility with minimal unanticipated questions.
- Ensure all appropriate CMC regulatory aspects to support license maintenance and change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines.
- Deliver CMC regulatory strategy to support major inspections (eg PAI's) or quality incidents (PIRCs).Work with subject matter experts to map current and future processes, seek efficiencies, and integrate written standards and training requirements.
- Manage multiple projects and teams simultaneously and provides data assessment and conclusions within and across departments.
- Formulate alternative approaches and influences people, systems and processes.
- Independently identify risks associated with submission data and information packages.
- Contribute to, and lead the creation, maintenance and continuous improvement of CMC Regulatory processes, policies and systems
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in Biochemistry, Pharmaceutical Chemistry or life sciences
- 5+ years of experience in the pharmaceutical industry
- Sound knowledge of biopharmaceutical drug development and manufacturing and supply processes
- Knowledge of worldwide CMC regulatory requirements for biopharmaceuticals
- Successfully managed multiple projects simultaneously.
If you have the following characteristics, it would be a plus:
- Regulatory Affairs Certification (RAPS).
- Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
- Broad knowledge base across regulatory functions to understand wider implications of emerging issues across projects
- Experience in influencing and negotiating with GSK personnel in a variety of settings.
- Highly developed interpersonal, presentation and communication skills with established internal and external networks
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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