Regulatory Manager, Strategy - CMC RA Vaccines Development Projects

About the role

Responsible for the CMC regulatory activities in the investigational, late phase development and/or early

commercial lifecycle management of GSK products.

About the responsibilities

- Be responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities

- Be responsible for CMC strategy development, with managerial support, for CMC submission documents from early phase clinical submissions (IND/IMPD) through to marketing applications (NDA/BLA/MAA)

and early lifecycle management activities in accordance with the applicable regulatory &

scientific standards.

- Understand, interpret and will sometimes advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of medicinal products, to expedite the

submission, review and approval of global CMC applications.

- Ensure 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. Ensure information submitted in

clinical/marketing applications meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.

- Work in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy.

- Maintain high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.

- Ensure regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions.

- Engage in CMC Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency).

- Will sometimes deliver CMC regulatory strategy to support major inspections (e.g. PAI's) with managerial support.

About you

- BSc Life sciences or related scientific discipline (or PhD)

- Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with direct involvement in regulatory submission preparation across all stages of development

through to early life cycle submissions.

- Sound knowledge of drug development, manufacturing processes and supply chain and may have a specialized area of expertise.

- Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply with these, particularly for new medicines in development.

- Good time management skills with the ability to effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines.

- Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has broadened own knowledge base across regulatory functions to understand wider implications of emerging issues across projects. Experience in influencing and negotiating with company personnel and with regulatory agencies in a

variety of settings.

- Strong interpersonal, presentation and communication skills with established internal networks.

- May be identified as CMC Regulatory expert in a specific subject area.

- Proactively seeks out and recommends process improvements

- Proven ability to develop and implement regulatory strategies and evaluate their potential impact on overall project/product strategy.

- Demonstrated ability to handle 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.)

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Skills

Communication, Digital Fluency, Influencing Without Authority, Learning Agility, Pharmaceutical Regulatory Compliance, Problem Solving, Regulatory Strategies, Strategic Leadership

 

 

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $113,850 to $189,750. • If you are based in another US location, the annual base salary range is $103,500 to $172,500. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.Polish Salary Range / Polski przedział wynagrodzenia: PLN 236,250 to PLN 393,750Italian Salary Range / Fascia retributiva in Italia: EUR 48,225 to EUR 80,375Belgium Salary Range / Fourchette salariale – Belgique: EUR 69,750 to EUR 116,250The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.Le salaire de base mensuel brut minimum pour les nouvelles recrues à ce poste est indiqué ci dessus pour chaque lieu applicable. Ce salaire de base mensuel brut minimum tient compte de plusieurs facteurs, notamment les compétences, l’expérience et le niveau de formation du/de la candidat(e), ainsi que le taux du marché pour le poste. En outre, ce poste peut donner droit à un bonus annuel ainsi qu'une éligibilité pour participer à notre programme de long term incentive basé sur des actions, en fonction du niveau du rôle. Des informations plus détaillées sur l’ensemble du package salarial seront fournies au cours du processus de recrutement. Ce poste étant ouvert à des candidat(e)s basé(e)s dans plusieurs pays, des fourchettes de salaire sont également indiquées pour certains lieux. Les fourchettes salariales pour d'autres localisations sont mentionnées parce que certains marchés ont des lois en matière de transparence salariale qui imposent que les informations sur les salaires soient affichées dans les offres d’emploi, et que ces pays sont des lieux potentiels pour ce poste. Si aucune fourchette salariale n’est indiquée dans l’offre d’emploi pour un lieu ou un pays spécifique, la rémunération correspondante sera discutée au cours du processus de recrutement. Veuillez noter que les salaires varient selon le pays en fonction des compétences, de l'expérience, du niveau de formation du/de la candidat(e) et du taux du marché pour le poste. Les offres sont généralement faites dans la fourchette annoncée en fonction des compétences, de l'expérience et des qualifications du/de la candidat(e), la partie haute de la fourchette étant généralement réservée aux profils très expérimentés ou à des circonstances exceptionnelles répondant à ces critères.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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