Regulatory Associate Director – Classic and Established Products

Job title:

Regulatory Affiliate Director – Traditional and Established Merchandise

Firm

GlaxoSmithKline

Job description

Regulatory Affairs Affiliate Director – Traditional & Established MerchandiseWe’re searching for a vivid and impressive Regulatory Affairs Affiliate Director or Supervisor to make sure the event of regulatory technique(ies) (excluding US) and their execution for assigned asset(s) according to the strategic actions for GSK’s Traditional & Established Product (CEP) portfolio. This objective must be achieved whereas guaranteeing compliance with each inner GSK course of / coverage and with applicable regulatory necessities.We create a spot the place folks can develop, be their finest, be protected, and really feel welcome, valued and included. We provide a aggressive wage, an annual bonus based mostly on firm efficiency, healthcare and wellbeing programmes, pension plan membership, and shares and financial savings programme.We embrace fashionable work practises; our Efficiency with Alternative programme presents a hybrid working mannequin, empowering you to search out the optimum stability between distant and in-office work.Uncover extra about our firm extensive advantages and life at GSK on our webpageIn conducting function, planning will probably be on a a number of yr horizon, with supply requiring intensive matrix working inside GSK to VP stage and representing GSK with regulatory businesses, together with instantly with the European Medicines Company and different European Native Authorities for Centralised and Mutual Recognition process merchandise. Work carefully with companion capabilities to safe finest regulatory technique to ship business and provide methods based mostly on obtainable information. Work with native regulatory operate to (co)- lead interactions with native / regional regulatory authoritiesOn this function you’ll

• Be sure that the regulatory technique delivers the wants of the International and regional tasks, whereas bearing in mind the regulatory wants of the native market(s).
• Take possession of a number of CEP portfolio Belongings appearing as International Regulatory Result in drive matrix crew engagement.
• Lead regulatory interactions and evaluation processes.
• Guarantee applicable interplay with regional and world business groups.
• Guarantee compliance with regional regulatory necessities.

Why you?Fundamental {Qualifications} & Expertise:We’re searching for professionals with these required expertise to realize our objectives:

• Bachelor’s diploma or ideally PhD in organic or healthcare science
• Expertise of all phases of the drug growth course of in regulatory affairs, with explicit emphasis on upkeep and lifecycle administration of marketed merchandise, together with for tasks with little or no priority.
• Able to main regional regulatory technique growth, submission and approval actions in native area(s).
• In depth data of licensing necessities in all main nations within the area and data of different key Company processes.
• Able to with the ability to develop product / therapeutic data in new space

Most popular {Qualifications} & Expertise:Please observe the next expertise will not be mandatory, simply most popular, when you would not have them, please nonetheless apply:

• Glorious communication expertise. Able to delivering key communications with readability, impression and keenness.
• Capacity to foster robust matrix working, facilitating dialogue between crew and matrix members to contribute their concepts.
• Brings crew members into the dialogue so that they contribute their concepts. Able to growing and recommending methods for change.
• Creating private networks inside GSK and able to utilizing them to safe applicable help and final result for a mission.
• Able to figuring out mission or crew points prematurely and in search of mandatory assist and help to resolve.
• Capacity to derive artistic options to regulatory issues, whereas balancing the expectations of Companies and guaranteeing compliance with regulation in all areas. Acknowledges and escalates potential long-term dangers for tasks/merchandise.
• Capacity to make use of a spread of sources and weigh advantages and dangers earlier than making vital selections.
• Concentrate on bettering efficiency and excellence by difficult the methods of working and able to growing and recommending methods for change.
• In a position to develop personal networks inside GSK and of securing applicable help and final result for a mission.

Please take a duplicate of the Job Description, as this is not going to be obtainable submit closure of the advert.
When making use of for this function, please use the ‘cowl letter’ of the web software or your CV to explain the way you meet the competencies for this function, as outlined within the job necessities above. The data that you’ve offered in your cowl letter and CV will probably be used to evaluate your software.Why Us?GSK is a worldwide biopharma firm with a particular goal – to unite science, expertise and expertise to get forward of illness collectively – so we are able to positively impression the well being of billions of individuals and ship stronger, extra sustainable shareholder returns – as a company the place folks can thrive. Getting forward means stopping illness in addition to treating it, and we goal to positively impression the well being of two.5 billion folks by the top of 2030.Our success completely will depend on our folks. Whereas getting forward of illness collectively is about our ambition for sufferers and shareholders, it’s additionally about making GSK a spot the place folks can thrive. We wish GSK to be a office the place everybody can really feel a way of belonging and thrive as set out in our Equal and Inclusive Remedy of Workers coverage. We’re dedicated to being extra proactive in any respect ranges in order that our workforce displays the communities we work and rent in, and our GSK management displays our GSK workforce.As an Equal Alternative Employer, we’re open to all expertise. Within the US, we additionally adhere to Affirmative Motion rules. This ensures that every one certified candidates will obtain equal consideration for employment with out regard to neurodiversity, race/ethnicity, color, nationwide origin, faith, gender, being pregnant, marital standing, sexual orientation, gender identification/expression, age, incapacity, genetic data, navy service, coated/protected veteran standing or another federal, state or native protected class*(*US solely).We consider in an agile working tradition for all our roles. If flexibility is vital to you, we encourage you to discover with our hiring crew what the alternatives are.Must you require any changes to our course of to help you in demonstrating your strengths and capabilities contact us on or 0808 234 4391.Please observe ought to your enquiry not relate to changes, we will be unable to help you thru these channels. Nonetheless, we have now created a UK Recruitment FAQ information. Click on the and scroll to the Careers Part the place you will discover solutions to a number of questions we obtainAs you apply, we’ll ask you to share some private data which is solely voluntary. We wish to have a possibility to contemplate a various pool of certified candidates and this data will help us in assembly that goal and in understanding how effectively we’re doing in opposition to our inclusion and variety ambitions. We might actually admire it when you might take just a few moments to finish it. Relaxation assured, Hiring Managers would not have entry to this data and we’ll deal with your data confidentially.Essential discover to Employment companies/ CompaniesGSK doesn’t settle for referrals from employment companies and/or employment businesses in respect of the vacancies posted on this web site. All employment companies/businesses are required to contact GSK’s business and basic procurement/human assets division to acquire prior written authorization earlier than referring any candidates to GSK. The acquiring of prior written authorization is a situation precedent to any settlement (verbal or written) between the employment enterprise/ company and GSK. Within the absence of such written authorization being obtained any actions undertaken by the employment enterprise/company shall be deemed to have been carried out with out the consent or contractual settlement of GSK. GSK shall due to this fact not be accountable for any charges arising from such actions or any charges arising from any referrals by employment companies/businesses in respect of the vacancies posted on this web site.Please observe that in case you are a US Licensed Healthcare Skilled or Healthcare Skilled as outlined by the legal guidelines of the state issuing your license, GSK could also be required to seize and report bills GSK incurs, in your behalf, within the occasion you’re afforded an interview for employment. This seize of relevant transfers of worth is important to make sure GSK’s compliance to all federal and state US Transparency necessities. For extra data, please go to GSK’s Transparency Reporting web site.We’re transferring in the direction of a extra sustainable future with our new headquarters. With higher public transport hyperlinks and proximity to world-class science and expertise establishments, we’re excited for our transfer to the neighborhood of Earnshaw Avenue, London WC1A (“the New HQ”) by finish H1 2024.

Anticipated wage

Location

Brentford, Better London – London

Job date

Solar, 07 Apr 2024 04:56:33 GMT

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