About Us
MSI Reproductive Choices is one of the world’s leading providers of sexual and reproductive healthcare. We believe that everyone should have the right to choose. From contraception to safe abortion and life-saving post-abortion care, we are committed to delivering compassionate, affordable, high-quality services for all.
Today, our organisation has over 9,000 team members working in 37 countries across the world. Our success lies in the fact that MSI teams are locally led, entrepreneurial and results-driven, and are passionate about delivering high quality, client-centered care in their own communities. As a social business, we focus on sustainable delivery, efficiency, and funding models that are built to last, so that the women and girls we serve today will have a choice in the future too.
We know that access to reproductive choice is life changing. For some, it can mean the ability to complete an education or start a career. For others, it means being able to look after the family they already have. For everyone, it means the freedom to decide their own future, creating a fairer, more equal world.
About the Role
The Regulatory and Compliance Specialist is part of the Global Supply Chain function. This function is a strategic activity within MSI, aimed at ensuring quality registered products are available in the territories noted in our business plans.
This role will be responsible to collaborate with and manage manufacturers to compose dossiers against the regulatory guidelines of each territory. The role is responsible to deliver against agreed timelines, the approved specifications and then reporting progress to all key stakeholders to ensure we can monitor success through KPIs.
This position will also work with MSIs 37 country programmes identifying appropriate product innovations and strategies for Social Marketing, including preparation of registration process and support in product development or sharing expert knowledge when needed.
Ensuring that other suitable complimentary products for the Social Marketing product portfolio are identified and qualified during interactions with manufacturers.
This role will work very cross-functional and whilst the reporting line is directly to the Regulatory and Compliance Manager, there is expected to be a large amount of work associated with our Social Marketing department where time-management will be a critical aspect of the role.
About You
We recruit talented, dynamic people with diverse backgrounds and experiences, all united by a belief in our mission and a focus on delivering measurable results. We’re proud to be an equal opportunities employer and are committed to creating a fully inclusive workplace, where everyone feels able to participate and contribute meaningfully. You must be open-minded, curious, resilient, and solutions-oriented, and committed to promoting equality, and safeguarding the welfare of team members and clients alike.
To perform this role, it is essential that you have the following experience:
- 5+ years in regulatory submission (In a range of therapeutical areas – reproductive health is highly desirable)
- Similarly 5+ years’ experience within the regulatory environments of import/export business.
- Considerable experience in pharmaceutical manufacturing sector or similarly regulated space
Skills:
To perform this role, it is essential that you have the following skills:
- Good understanding of local regulatory and legislative requirements (preferably with experience in Africa, Asia and Latin America)
Desirable
- Expertise in CTD/ACTD/Non-ACTD dossier preparation
Education/Qualifications
- Educated to degree level within a Health or Medical area of specialism, or equivalent experience (essential)
- Pharmaceutical degree is highly desirable
- Project management trained or suitably qualified through experience
- Regulatory training and trained in Good Distribution / Manufacturing Practice
- Proficient in English (essential) & French (highly desirable)
Personal Attributes:
We seek exceptional individuals who are aligned to MSI’s mission and entrepreneurial mindset. You must be a strong communicator, self-motivated and solutions-seeking, committed to driving social change in an environment that measures sustainable results and impact at an individual and global level. You must be able to work effectively with and across diverse teams and be comfortable with ambiguity.
For this role, we’re looking for an individual who is/has:
- a resilient, flexible and overly positive person
- pragmatic in their attitude with a willingness to adapt plans to changes in circumstances/direction as the strategy or feedback dictates
- actively seeking feedback on performance (both results and behaviours) from various stakeholders in the organisation with a view to continuously learning and growing
- willing to travel up to 10% of the time to geographically challenging locations
- able to work efficiently and comfortably in a diverse multinational environment
- able to work with minimal supervision to achieve the objectives of the workplan
For more information about the role, please view the job description and person specification on our website.
Location: Dhaka, Bangladesh or India
Full-time: 40 hours per week
Contract type: Permanent
Salary: The role will be banded within the national context
Closing date: 7th May 2023 (midnight GMT+1). Interviews may take place before this date for exceptional candidates.
For internal employees applying from an MSI country programme, the role will be positioned within the existing salary structure of the country. Local terms and conditions of the country will apply.