▷ Only 24h Left: Reg Associate Manager I

Business Introduction At GSK we have bold ambitions for patients aiming to positively impact the health of 2 5 billion people by the end of the decade Our R D focuses on discovering and delivering vaccines and medicines combining our understanding of the immune system with cutting-edge technology to transform people s lives GSK fosters a culture ambitious for patients accountable for impact and committed to doing the right thing making sure that we focus our efforts on accelerating significant assets that meet patients needs and have the highest probability of success We re uniting science technology and talent to get ahead of disease together Find out more Position Summary This is an exciting opportunity to play a key role in supporting regulatory activities for new product registrations and lifecycle management You will collaborate with global and local teams to ensure timely and compliant submissions that align with regulatory requirements We are looking for a detail-oriented and proactive individual who is passionate about making a meaningful impact on global healthcare Join us to grow your career while contributing to GSK s mission of uniting science technology and talent to get ahead of disease together Basic Qualification Independently and confidently executes agreed dossier strategy Independently manages multiple Rx and or Vx project assignments simultaneously assignments will range in complexity but more complex work is expected Independently completes data assessment to ensure dossier is fit for purpose Identifies risks associated with submission data and information packages Escalates issues with line manager that have business impact May act as reviewer approver for dossiers prepared by peers and identifies improvement opportunities for Regulatory processes policies and systems Understands regulations guidelines procedures and policies relating to registration and manufacturing of pharmaceutical products to expedite submission review and approval of global applications May provide consultation and solutions being the subject matter expert in specific areas of expertise Acts as mentor trainer for new staff Understands internal external Regulatory environment Actively builds an organisational network PSC LOC PO and other relevant stakeholders promotes and is engaged in knowledge and experience sharing Communicates across GSK as necessary regarding project and policy issues ensuring optimum position for GSK Preferred Qualification If you have the following characteristics it would be a plus Master s degree in a relevant field Broad understanding of the pharmaceutical industry drug development environment and R D processes and objectives Global Regulatory submission experience - Knowledge of regulatory agency guidelines Excellent organizational skills attention to detail and commitment to deliver high quality output even under pressures sometimes demanded by regulatory deadlines Excellent written and verbal communication skills and ability to present information in a clear and concise manner Ability to interpret and advise on guidelines and requirements on a global basis reflecting recent GSK experience Ability to build effective working relationships and work in a matrix environment effectively Ability to think flexibly in order to meet constantly shifting priorities and timelines Work Arrangement This role is based in India and follows a hybrid working model combining remote and on-site work We are looking for individuals who are passionate about making a difference and thrive in a collaborative fast-paced environment If this sounds like you we encourage you to apply 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 Inclusion at GSK As an employer committed to Inclusion we encourage you to reach out if you need any adjustments during the recruitment process Please contact our Recruitment Team at IN recruitment-adjustments gsk com to discuss your needs 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 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 It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way GlaxoSmithKline does not charge any fee whatsoever for recruitment process Please do not make payments to any individuals entities in connection with recruitment with any GlaxoSmithKline or GSK group company at any worldwide location Even if they claim that the money is refundable If you come across unsolicited email from email addresses not ending in gsk com or job advertisements which state that you should contact an email address that does not end in gsk com you should disregard the same and inform us by emailing askus gsk com so that we can confirm to you if the job is genuine