Regulatory & Quality Specialist

Job description

The Position

At Roche, we believe it’s urgent to deliver medical solutions right now, even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are brave in both decision and action and we believe that good business means a better world. Join us in making this happen.

• Sr. Executive/Specialist (individual contributor) level role

• Cohesive and supportive team

• Regional and global exposure 

Regulatory & Quality Specialist is a customer-facing role that manages local regulatory activities, including identifying and addressing the relevant regulatory needs of clinical practice, supporting the registration, renewal of existing & new Roche products in the affiliate. They have the ability to link affiliate to Global PDR & PTR teams to deliver timely data generation, knowledge exchange/ data communications, and lead local HA engagement in a scientific manner.

Regulatory & Quality Specialist also supports and implements all quality systems in scope of product complaints and supply chain & logistics by linking local distribution operations as per Roche and GMP/GDP standards, Roche Pharmaceutical Quality System (PQS) and local regulatory requirements.

Key Responsibilities include but not limited to the following:

Regulatory Affairs (80%)

• Offering regulatory expertise and input into cross-functional Affiliate business strategies

• Developing innovative, risk-based registration plans and submissions strategies

• Adapting global product dossiers to local requirements, ensure accuracy and maintain all the submission and approved dossiers in related systems

• Preparing and managing regulatory registration filings across product life cycles

• Monitoring and communicating all regulatory filings status and responding to internal and external questions

• Developing and maintaining current knowledge of international and local regulations and other governing regulatory practices, policies, procedures and standards

• Ensuring regulatory inspection-readiness for the Affiliate, as per assigned responsibilities

• Training internal customers on SOPs/systems/processes as required

• Managing end-to-end local product packaging and labelling from a regulatory perspective

• Facilitating local submission and approval of promotional/non-promotional materials from local regulatory bodies (DGDA)

Quality Assurance (20%)

• Acting as representative and point of contact for the local, regional and global quality organization

• Ensuring all local procedures and systems comply with Roche PQS, GMP/GDP requirements and local regulatory requirements including effective implementation of artwork

• Handling product complaints and supporting Dubai PV Hub for performing monthly QC on Products Complaint

• Managing the GMP/GDP deviations and investigation in compliance with the applicable requirements

Who you are:

You have a Bachelor's degree in Pharmacy, Health Sciences, or related field. Post graduate degree in Pharmacy or related discipline preferred.  

You have:

• Experience in local regulatory field within Pharmaceutical industry including dealing with biological molecules, having experience in quality assurance a plus

• Experience in working with various system based regulatory tools and platforms (i.e. Regulatory Information Management - RIM) being Tech Savvy

• Good customer engagement and management skills

• Experience in working with cross functional teams and formulating strategies, proactive with problem solving capacities

• Knowledge of relevant national regulation standards and compliance guidelines

• Good communication skills both in Bangla and English

You have a growth mindset who takes risks and experiments, and contributes to the learning cycle by sharing knowledge with others inside and outside Roche. With an enabler mindset, strong interpersonal skills and empathy  you can leverage the internal and external networks to create value.

This role may require domestic/international travel and is only open to candidates that have full eligibility to live and work in Bangladesh. Due to time zone differences, some evening and weekend work may be required.

What do we offer?

In return, Roche offers an agile work environment with ample opportunities for career advancement with local, regional and global exposure. Roche encourages a high-performance culture where you are empowered and trusted to make decisions. We strive for excellence and extraordinary results and take a genuine interest in our people and their well-being, and our patients.

At Roche, the world’s largest biotech company, with the industry’s strongest pipeline in specialised medicines, you can make a difference to millions of patients worldwide developing treatments for oncology, neuroscience, inflammation, immunology, ophthalmology, rare diseases, and respiratory disease.

Anything’s possible, in a friendly, collaborative culture where people are united in purpose and will stretch you to be brave, speak up and think differently. Feel empowered to deliver meaningful outcomes, supported by accessible and inspiring leaders.

All facets of diversity are important to us and we endeavour to create an environment where everyone, regardless of factors such as gender, age, ability, race, ethnicity, sexual orientation, gender identification or religion, can contribute and realise their potential. As part of promoting diversity, we welcome applications from all people who are passionate about doing now what patients need next.

We do not accept any unsolicited resumes or enquiries from recruitment agencies. Roche has a dedicated in-house Talent Acquisition team.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.