Senior RA CMC Manager

7 months ago

Beijing, China 1215 GlaxoSmithKline (China) Investment Co Ltd Full time

Role Purpose ：

To provide strategic and technical CMC regulatory input for the purpose of commencing and maximizing GSK China business by facilitating the CMC submission and approval in a timely and high-quality manner.

Key Accountabilities/Responsibilities ：

In charge of all CMC regulatory relevant activities of assigned new products (IND/CTA/NDA) and established products (life cycle management), including CMC strategy making and implementation, CMC document preparation, CDE CMC technical review follow up, HA CMC meeting or communication for CMC topics, QC testing, GMP on-site inspection, ChP, bundling review, etc. Provide strategic and technical regulatory CMC input and support to line manager to contribute for decision making on new drug CMC development strategy and license maintaining CMC strategy to deliver the highest value to business. Independently compile high quality CMC filing document complying with external and internal requirement to provide right and clear drug profile and data to HA to achieve targeted labeling and drug features to be approved. Independently engage with internal and external CMC stakeholders to follow up every CMC milestone closely to ensure issue identified, escalated, resolved timely and target CMC filing and approval timeline plan is achieved. Establish and maintain a good relationship with key CMC regulatory authority in daily work such as NMPA, CDE, NIFDC, CPC, etc via professional communication. Make sure line manager fully informed CMC projects registration status in daily work. Provide timely and high-quality CMC regulatory support and input to internal key stakeholders such as medical, commercial and GMS site as needed. Significantly contribute or lead function continuous improvement initiative Ensure timely and flawless implementation of company SOP and compliance requirement in daily work.

Qualifications/Requirements: (Education / Experience / Competencies)

A minimum of master’s degree in life science (pharmacy, chemistry, biology or related background) Minimum 6 years’ experience in regulatory affairs/CMC field and at least 3 years in MNC Proven ability to communicate (written/oral) with various functions and with authority. Fluency in English Ability of cross functional co-operation. Strong ownership and cross boundary working mindset A strong capability in problem solving Strong ability of lobby, influence and negotiation Ability to coordinate, influence and lead a virtual team

Why GSK?

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

GSK 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.


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.

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