CMC Regulatory Affairs Associate Director (Biologics)

Company: GlaxoSmithKline
Location: Rockville
Posted on: May 26, 2023

Job Description:

Site Name: USA - Massachusetts - Waltham, Belgium-Wavre, Switzerland - Zug, UK - London - Brentford, USA - Maryland - Rockville, USA - Pennsylvania - Upper ProvidencePosted Date: Apr 5 2023Are 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,coordinatesthetimelypreparationand authors, as needed,technical (CMC) regulatorydocumentstosupport lifecycle maintenance submission content,in accordance withthe applicable regulatory& scientificstandards,and taking into accountthe 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 establishorganisationalnetworks (internal and external) understandingdepartmentalconstraints/pressurewithinahighlycomplexorganisation. . Engages and may lead CMC Subject Matter Expert activities, both internally (for increased compliance,harmonisationand efficiency)and externally(external advocacy and shapingtheregulatory 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.Why you?Basic Qualifications: B.Sc. in Life Sciences or related scientific disciplines - To ensure a good understanding of the science behind physical product manufacture, and the associated regulatory challenges with maintaining a compliant supply chain.

• Experience of drug development and manufacturing and supply processes and may have a specialized area of expertise.
• Working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
• Project management experience.
• Experience in major post approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management).Preferred Qualifications: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 ofsettings.
  • Demonstrated ability to handle complex global CMC issues through continuous change and improvement.
  • 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 teamleadership.
  • 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.Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader inConsumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggestchanges 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 geneticsscience; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of diseasetogether - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; andas a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culturethat isambitious for patients- so we deliver what matters better and faster; accountable for impact- with clear ownership ofgoals and support to succeed; andwhere we do the right thing. So, if you're ready to improve the lives of billions, join us at thisexciting moment in our journey. Join our challenge to get Ahead Together. *LI-GSK#WYARD2022GSK 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 impact the health of 2.5 billion people around the world in the next 10 years.Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.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/ AgenciesGSK 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 site.

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