Senior Regulatory Specialist

GSK

Bengaluru Luxor North TowerPosted 4 days agoDiscoveredMatch locked

On-siteFull time3+ years exp

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: Our approach to R&D Position Summary

• Represents

CMC Delivery team on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3 rd Party Contract Manufacturing Organizations and Office of the Chief Medical Officer (OCMO) to produce appropriate components for global regulatory dossiers.

Role requires a general understanding of submission requirements for multiple countries/ submission types and an ability to work in a matrix environment.

Responsible for timely delivery of regulatory activities of multiple

Vx projects across dosage forms

Will serve as a mentor/trainer for new team members.
May act as a Subject Matter Expert for specific areas for consultation within

the team/ department as well as externally outside the department.

Responsibilities

Independently manages multiple Vx CMC regulatory submission assignments simultaneously; assignments will range in complexity, but more complex work is expected.
Independently and confidently executes agreed dossier strategy.
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

Working in complex environment within a scientific organization

Minimum 3-8 years of experience

Bachelor's degree.( Chemistry, pharmacy or other related science or technical bachelor's degree.
Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
Global/ EMAP Regulatory submission experience - Knowledge of regulatory agency guidelines
Excellent organisational 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 on-site in India. You will collaborate closely with local and global colleagues and participate in virtual meetings. If you want to take your regulatory career to the next level while making a real difference in patient lives, we want to hear from you. Apply now and share how your experience fits this important role. If you need any support during the recruitment process, please let us know so we can help.

Skills

Polish Salary Range / Polski przedział wynagrodzenia: PLN 144,750 to PLN 241,250The 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.

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.

Not included in the source posting: about the role, what you'll do, benefits.

Who can apply

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