Job title : Lead - Internal Regulatory Affairs
Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally .
Our mission is to bring health in people’s hands by making self-care as simple as it should be . For half a billion consumers worldwide – and counting.
At the core of this mission is our 100 loved brands , our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.
B Corp certified in multiple markets , we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com .
About the job:
Mission & Tasks
At Opella, our mission is to transform science into simple solutions that put the patients/consumers at the
center of everything we do. We believe that self -care is a powerful tool for promoting health and well-being.
We are dedicated to creating products that make daily personal care easier, making science accessible and
a part of people's everyday lives.
The mission of the Lead-Internal Regulatory affairs is to assist in navigating and facilitating the regulatory
landscape, ensuring that the company’s products comply with all applicable laws and regulations while
supporting business objectives.
Contribute to the preparation and submission of dossiers, respond to
inquiries from regulatory authorities, and obtain the necessary approvals for product marketing and
distribution. Provide support to global functions when needed.
This role requires a solid understanding of regulatory frameworks, strong communication skills, and the
ability to collaborate with various functions within the organization.
Additionally, ensure that internal projects progress efficiently and achieve regulatory compliance within the
required timelines.
Main responsibilities:
- Collaborate with Local and Global Functions, External manufacturing, R&D, Quality Assurance,
Marketing, and other departments to ensure regulatory requirements are considered in product
development and post-market activities.
- Provide regulatory guidance to support changes to existing products;
- Mentor the regulatory operation manager to ensure timely preparation and submission of regulatory
documents to Health Authorities; adhere to submission timelines to ensure timely approvals and
escalate any possible risk to local and global teams.
- Regulatory consultation and advice, including but not limited to verification of regulatory strategies
and timelines.
- Address any regulatory issues or challenges that arise during a project, working collaboratively with
relevant stakeholders to identify solutions and mitigate potential impacts on timelines or project
objectives.
- Identify and assess regulatory risks associated with product commercialization, developing
strategies to mitigate those risks effectively.
- Participate in the evaluation of promotional materials, ensuring they comply with current legislation
- Establish and maintain positive relationships with regulatory authorities in India;
- Act as a point of contact with regulatory agencies, responding to inquiries and requests for additional
information for the assigned CHC brands or internal projects
- Contribute to influencing regulatory bodies and health authorities by actively participating in
meetings/committees and building relationships to review and update legislation, assess business
impacts, and provide clarifications on projects and products
- Promote compliance with internal processes, metrics, and controls, focusing on portfolio
registrations and their maintenance.
Management Responsibilities:
- Represent the company with relevant government agencies and key associations;
- Report activities to Science Hub Head India;
- Lead LCM activities for all brands in India and ensure products comply with all applicable laws.
Manage registration of new products in India and ensure that the company's products comply with all
applicable laws and regulations while supporting business objectives.
Scope :
- Develop regulatory strategy and execute new product, LCM (Life Cycle Management)
regulatory activities across all brands, and assist in making regulatory decisions and executing
tasks related to local INNs.
About you:
- Bachelor’s degree in pharmacy, Life Sciences, or a related field. Masters’ degree preferred.
Experience in Regulatory Affairs, preferably within the pharmaceutical /FMCH industry.
- Proven experience in regulatory strategy, LCM management for regulatory activities
- Strong knowledge of regulatory frameworks and requirements in India and an understanding
of global regulatory processes.
- Ability to work collaboratively with cross-functional teams, including R&D, Marketing, Quality,
and other departments.
- Excellent organizational skills with the ability to manage multiple projects and timelines
simultaneously.
- Strong communication skills
Why us?
At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.
We Are Challengers.
We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:
All In Together: We keep each other honest and have each other's backs.
Courageous: We break boundaries and take thoughtful risks with creativity.
Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.
Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.
Join us on our mission. Health. In your hands.
www.opella.com/en/careers
