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Regulatory Affairs Associate

3 months ago

Bengaluru, India Indegene Full time

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out

What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it?

We understand that you are looking for growth in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career with the reliability you seek. We believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers.

We are a rapidly growing global organization and are scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. The combination of this will lead to a truly differentiated experience for you.

If this excites you, then apply below.


Job Description:

ROLE PURPOSE: Candidate will be responsible for preparing and managing regulatory dossiers, coordinating with regulatory authorities for EU and ASEAN markets and providing guidance on regulatory requirements to internal teams

SKILLS:

• Good communication skills (Written and Oral)

• MS Office (Excel and Power point), Adobe Professional • Desirable to have hands on experience on RIMS preferably Veeva Vault, Trackwise PRINCIPAL RESPONSIBILITIES:

• Thorough knowledge of EU & ASEAN markets - country requirements/regulatory affairs procedures for initial submission, licensing, post approval submission management

• Experience with global regulatory submission formats, including familiarity with submission publishing activities

• Organizes, leads, and facilitates and or participates in cross functional meetings with stakeholders

• Understands the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across EU & ASEAN markets

• Leads and / or contributes to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.

• Hands-on experience on regulatory document management systems and publishing tools

• Able to support and prepare Module 1 documents - submission form, cover letter, notification forms, comparison tables for regulatory submission

• Uses and shares best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment

• Review the content prepared by junior team members. Validate the authenticity of the content by performing QC of the dossier prepared

• Coordinate with cross-functional teams, including R&D, quality assurance, and manufacturing, to gather necessary information and documentation for dossier preparation

• Tracks timely delivery of submission components, coordinates submission publishing activities with publishing team and organizes internal review and approvals.

• Tracking and maintaining the submission trackers

• Identifies regulatory risks and proposes mitigations to Lead and cross functional teams

• Ensure submission/query/additional request by HA should be communicated to the global colleagues through agreed process

• Able to extract regulatory intelligence information (requirements for CTA, drug/device/cosmetic/food registration etc.)

• Provides coaching, mentoring and knowledge sharing within the regulatory organisation

• Mentoring of new joiners with respect to SOPs and processes

• Exhibit flexibility in moving across new projects and preparation of multiple document types

• Continuously enhance and maintain knowledge of various writing guidelines for different deliverables by doing various assignments

• Understand various target audience and methods to approach different deliverables

• Volunteer in training programmes to develop skills in areas relevant to the job in addition to the areas of interest.


EDUCATION: BPharm / MPharm/ Pharm D/ MSc


EXPERIENCE: Required 4-6 years of experience in EU/ASEAN markets



EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.