Regulatory Affairs Manager/Associate Director Respiratory, Established Products

Job title:

Regulatory Affairs Supervisor/Affiliate Director Respiratory, Established Merchandise

Firm

GlaxoSmithKline

Job description

We’re on the lookout for an bold Supervisor/Affiliate Director of Regulatory Affairs to make sure the event of acceptable world and/or regional regulatory life-cycle technique(s) and their execution for assigned merchandise to fulfill the wants of the enterprise. This purpose needs to be achieved while making certain compliance with each inside GSK course of / coverage and with acceptable regulatory necessities to ship the very best life cycle administration and growth commensurate with the accessible information, and thru optimum life cycle upkeep help.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 primarily based on firm efficiency, healthcare and wellbeing programmes, pension plan membership, and shares and financial savings programme.We embrace fashionable work practises; our Efficiency with Selection programme gives a hybrid working mannequin, empowering you to search out the optimum stability between distant and in-office work.Uncover extra about our firm huge advantages and life at GSK on our internet web pageAccountable to Senior Director of Respiratory Established Merchandise and VP, World Regulatory Established Merchandise for growth of acceptable world and/or regional regulatory life cycle technique(s) (growth, administration, and upkeep) and for supply based on plans. In conducting position, planning can be on a a number of yr horizon, with supply requiring in depth matrix working inside GSK to VP stage and representing GSK with a minimum of the native regulatory company. Work with the GRL and/or Drugs Improvement Group/Drugs Business Group (MDT/MCT), to make sure a strong regulatory technique is in place to help the regulatory life-cycle technique and meet the wants of the important thing markets. Work intently with native / regional business group in prioritized nations to ship the very best life-cycle administration commensurate with accessible information and in keeping with the GDS. Lead interactions with native / regional regulatory authorities.On this position you’ll

• Proactively develop regulatory life-cycle technique (growth, administration, and upkeep) that can ship the wants of the native area(s), taking in to account the wants of different areas globally.
• Implement the regional technique(s) in help of the worldwide regulatory life-cycle technique.
• Lead regulatory interactions and the overview processes in native area.
• Guarantee efficient partnerships with stakeholders and senior leaders throughout GRA, security, world medical and business groups and native regulatory counterparts in key markets.
• Guarantee compliance with world/ regional necessities and supply of unfulfilled regulatory commitments.
• Ideally assess precedent, regulatory intelligence and aggressive setting from a regulatory perspective for the area and the affect this may have on the regulatory technique for a product

Why you?Primary {Qualifications} & Abilities:We’re on the lookout for professionals with these required abilities to attain our targets:

• BSc in Organic or Healthcare Science or equal
• Expertise of life-cycle administration together with medical line extensions of the drug growth course of in regulatory affairs most well-liked.
• Able to main regional life-cycle growth methods and delivering submission and approval actions in native area(s)
• Information of medical trial and life-cycle administration licensing necessities in key markets within the area and ideally information of different key Company processes globally.
• Information of related remedy space, and skill to additional develop obligatory specialist information for the product or remedy space.
• Means to foster robust matrix working. Facilitates dialogue between group and matrix members to contribute their concepts. Able to creating and recommending methods for change.
• Good communication abilities, particularly in writing. Able to delivering key communications with readability, affect and fervour

Most popular {Qualifications} & Abilities:Please be aware the next abilities aren’t obligatory, simply most well-liked, should you should not have them, please nonetheless apply:

• PhD in Organic or Healthcare Science or equal
• Fixed concentrate on enhancing efficiency and excellence in all duties. Challenges and questions methods of working to hunt improved course of. Seeks to boost ranges of efficiency by establishing or enhancing course of.
• Ideally good listening and comprehension abilities; proactive in figuring out potential points and escalating them accordingly.
• Good total enterprise acumen. Understands the wants of and interdependencies with, different features. Understands the aggressive panorama within the business area to help life-cycle methods.
• Able to figuring out product or group points prematurely and in search of obligatory assist and help to resolve.
• Means to derive artistic options to regulatory issues, whereas balancing the expectations of Companies and making certain compliance with regulation in all areas. Recognises potential long-term points for merchandise.

Closing Date for Functions – Sunday twenty fourth March 2024 (COB)Please take a duplicate of the Job Description, as this won’t be accessible publish closure of the advert.
When making use of for this position, please use the ‘cowl letter’ of the web utility or your CV to explain the way you meet the competencies for this position, as outlined within the job necessities above. The knowledge that you’ve got supplied in your cowl letter and CV can be used to evaluate your utility.Why Us?GSK is a world biopharma firm with a particular goal – to unite science, know-how and expertise to get forward of illness collectively – so we are able to positively affect the well being of billions of individuals and ship stronger, extra sustainable shareholder returns – as a corporation the place folks can thrive. Getting forward means stopping illness in addition to treating it, and we goal to positively affect the well being of two.5 billion folks by the tip of 2030.Our success completely is dependent upon 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 Therapy of Staff 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 each 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 id/expression, age, incapacity, genetic data, navy service, lined/protected veteran standing or some other federal, state or native protected class*(*US solely).We consider in an agile working tradition for all our roles. If flexibility is essential to you, we encourage you to discover with our hiring group 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 be aware ought to your enquiry not relate to changes, we won’t be able to help you thru these channels. Nevertheless, we’ve created a UK Recruitment FAQ information. Click on the and scroll to the Careers Part the place one can find solutions to a number of questions we obtainAs you apply, we’ll ask you to share some private data which is totally voluntary. We wish to have a chance to think about a various pool of certified candidates and this data will help us in assembly that goal and in understanding how effectively we’re doing towards our inclusion and variety ambitions. We’d actually recognize it should you may take a couple of moments to finish it. Relaxation assured, Hiring Managers should not have entry to this data and we’ll deal with your data confidentially.Vital discover to Employment companies/ CompaniesGSK doesn’t settle for referrals from employment companies and/or employment companies in respect of the vacancies posted on this website. All employment companies/companies 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 responsible for any charges arising from such actions or any charges arising from any referrals by employment companies/companies in respect of the vacancies posted on this website.Please be aware that if you’re 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 website.We’re shifting in the direction of a extra sustainable future with our new headquarters. With higher public transport hyperlinks and proximity to world-class science and know-how 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, Larger London – London

Job date

Solar, 10 Mar 2024 04:59:02 GMT

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