Regulatory Associate Manager - Product Variations-1

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

• 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.

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

• 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 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

• Bachelor’s degree.( Chemistry, pharmacy or other related science or technical bachelor’s degree.

• Working in complex environment within a scientific organization
  Minimum 3-8 years of experience

• 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 work closely with local and global colleagues and may join cross-site virtual meetings.

What to expect next
If you are ready to grow your regulatory career and help deliver meaningful patient impact, we want to hear from you. Please apply and tell us how your skills and experience match this role. If you need any adjustments during the recruitment process, please let our recruitment team know so we can support you.

The annual base salary in Poland for new hires in this position ranges from PLN 144,750 to PLN 241,250 gross, taking into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non-discretionary criteria) and/or awards for exceptional performance (granted at the employer’s discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave.

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.

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