Senior Director, Regulatory Chemistry Manufacturing and Controls (CMC) Biopharm
Site Name: USA - Massachusetts - Waltham Posted Date: Jun 4 2021 Are you an experienced Biopharm CMC Regulatory Affairs Leader looking to make a broader impact in developing and commercializing safer and more effective supportive care agents and therapeutics? If so, this Senior Director, CMC Regulatory Affairs Biopharm role is an ideal opportunity to explore ! You are responsible for : - developing and implementing global regulatory strategy for biopharmaceutical products. - working with R&D, - developing and leading the product strategy and oversee the direction of commercial and clinical products in global markets. In addition, you play a key part in GSK's commitment to making a difference to patients' lives enabling them to Do More, Feel Better and Live Longer. This role can be based at our sites at Waltham, MA or Collegeville, Pennsylvania. This role will provide you the opportunity to lead key activities to progress your career, these responsibilities include some of the following: Accountable for CMC (Chemistry, Manufacturing and Controls) Regulatory activities for GSK biopharm development products, including in-licensed assets through early lifecycle. Accountable for delivering CMC strategy and advice for all GSK development products, ensures timely advice and strategy to project teams so as to secure regulatory approvals for clinical trial, marketing application, and early lifecycle change approvals worldwide. Provides CMC Regulatory representation to governance boards. Establishes and directs appropriate agency communications including End of Phase 2, Pre BLA, Scientific advice and ad-hoc product specific agency dialogue. Ensures risk assessments are conducted and appropriate mitigation and treatment plans are defined for product developments, effectively liaising with business partners and customers development and commercial manufacturing teams. Provides appropriate GSK representation and input to product specific inspections for CMC aspects to secure approvals of new products and lifecycle changes, and ensure GSK learning and continuous improvement. Key Responsibilities: Directs teams which provide the primary interface with development and commercial manufacturing teams. Responsible for managing direct agency interface for CMC product specific aspects for all GSK biopharm development assets and for ensuring effective negotiation of CMC agreements on behalf of development and commercial manufacturing teams. Manage resource requirements Accountable for CMC regulatory strategies and submission of global CMC applications aligned with GSK business needs for new biological entities and new dosage forms Embraces and drives change in regulatory approaches, seeking new and effective approaches which are aligned with emerging technology, regulatory expectations and applicable laws and regulations. Manages, coaches, and mentors staff across CMC RA on lifecycle management in CMC Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: BA/BSc in science discipline with 10+ years of biopharmaceutical regulatory CMC experience Experience across biopharm product types (mAbs, therapeutic proteins) and therapeutic areas GSK supports. Experience in formulating regulatory approaches to new and emerging guidance globally and regulatory experience across global markets Experience in scientific and regulatory in all stages of product development; Knowledge in IND and NDA/BLA regulations and US regulations pertinent to product development and licensure Preferred Qualifications: If you have the following characteristics, it would be a plus: Extensive understanding and experience of product development and technical regulatory requirements. Extensive expertise of diverse market environments and requirements. Proven ability to assimilate new and emerging requirements and establish optimized approach in global context. Extensive development experience including previous roles within product development, deep expertise and understanding of regulatory agencies worldwide and proven ability to effectively interface and communicate with global regulatory agencies. Extensive expertise of diverse market environments and requirements. Proven ability to assimilate new and emerging requirements and establish optimized approach in global context. Proven and effective line management capability Understanding and extensive experience of product development and technical regulatory requirements. Extensive expertise of diverse market environments and requirements. Proven ability to assimilate new and emerging requirements and establish optimized approach in global context. Extensive development experience including previous roles within product development, deep expertise and understanding of regulatory agencies worldwide and proven ability to effectively interface and communicate with global regulatory agencies. Extensive expertise of diverse market environments and requirements. Proven ability to assimilate new and emerging requirements and establish optimized approach in global context. Proven and effective line management capability Why GSK? Our values and expectations are 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: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk. Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *This is a job description to aide in the job posting, but does not include all job evaluation details. *LI-GSK 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.