Regulatory Affairs Associate

7 days ago

Bengaluru, India Parexel Full time

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
- Full Time
- Travel: Yes
- Glassdoor Reviews and Company Rating

**Success Profile**:
Check out the top traits we're looking for and see if you have the right mix.
- Detail-Oriented
- Proactive
- Problem-Solver
- Results-Driven
- Organized
- Multi-Tasker

**Rewards**:

- **Global Impact**: We are one truly global team working together to propel each client´s journey ahead faster.
- **Balance**: We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
- **Freedom**: The ability to innovate, ask “what if” and try new solutions without fear of failure.
- **Variety**: Opportunities to work on multiple accounts - never boring
- **Management**: Strong management with depth of experience working for global health authorities.

1. 2-4 yrs of experience in a regulatory environment with preference given to drug/device/biologic-related industry, and experience with electronic publishing of regulatory submissions.

2.Compilation, publishing, and technical quality control of Regulatory submissions

(Nees, paper and eCTD format) including technical troubleshooting to ensure issues within submissions are resolved and deadlines met.
3. Creation of cross-references, table of content, tab / slip-sheets, and volumes for Paper submissions.
4. Performing bookmarking, hyper-linking, and tables of content creation according to Health Authority (HA) guidelines for Electronic Submissions.

5. Knowledge of medical/scientific terminology, ICH guidelines and regulations and procedures preferred. Knowledge of submission requirements of various markets such as USFDA, EMA etc. is preferable.

6.Good communication, organizational, and interpersonal skills.

7. Knowledge of submission dispatches to Health Authorities is preferrable.

Qualification

B.Pharm
- Regulatory Affairs/M. Pharm
- Regulatory Affairs

  • Regulatory Affairs Associate

    11 hours ago

    Bengaluru, Karnataka, India Planet Science Full time

    **About Us**: An established player in the B2B Pharma raw material space has recently launched an exciting new E-commerce platform **- CLYZO** **Position - Regulatory Affairs Associate.** An organization with a reputed history of 10+ years in the Pharma raw material industry, dealing in excipient products is looking for Regulatory Affair Executive having...

  • Regulatory Affairs Career

    2 days ago

    Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 28,00,000

    Job Opportunity: Regulatory Affairs ProfessionalThe role of the Regulatory Affairs Associate I is a vital component in ensuring our products meet regulatory requirements.This includes:Evaluating change controls for registration impact and implementing necessary dossier changes in Europe and International Markets.Key Responsibilities:Compile variation...

  • Regulatory Affairs Professional

    2 weeks ago

    Bengaluru, Karnataka, India beBeeRegulatory Full time

    Regulatory Affairs ProfessionalThe ideal candidate will be responsible for working closely with international regulatory teams to ensure compliance with Indian regulations.Develop and maintain in-depth knowledge of India's Medical Device Regulations (MDR).Collaborate with cross-functional teams to implement effective regulatory strategies.Identify and...

  • Regulatory Affairs Associate

    3 days ago

    Bengaluru, India Antal International Full time

    Job Description **Job Title**: Regulatory Affairs Associate **Department**: Regulatory Affairs and Quality Compliance **Position at**: Bangalore **Position’s Objective & Summary**: Self-starter, executes the Regulatory strategy for obtaining registration approval of the company portfolio, according to plan. With limited supervision, coordinates and...

  • Associate Director Regulatory Affairs

    3 weeks ago

    Bengaluru, Karnataka, India Biocon Biologics Full time

    Job TitleAssociate Director / Sr. Manager - Global Regulatory AffairsDepartment:Regulatory AffairsResponsibility:Africa, Middle East, CIS & Non-EEAKey Responsibilities:1. Regulatory Strategy & PlanningDevelop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries.Ensure...

  • Associate Ii, Regulatory Affairs Strategy

    2 weeks ago

    Bengaluru, Karnataka, India Alcon Full time

    Summary of the Position: Regulatory Affairs Associate is responsible for providing support in ensuring compliance with EU, US, and global medical device regulatory requirements. This position is primarily focused on supporting international registration requirements triggered by the EU Medical Device Regulation (Regulation (EU) 2017/745, as amended). The...

  • API Regulatory Affairs

    1 week ago

    Bengaluru, Karnataka, India Biocon Ltd Full time ₹ 15,00,000 - ₹ 20,00,000 per year

    RoleAPI Regulatory Affairs DMF Filing/ Compilation (Global market)Level Associate Manager / Manager Level:-Required Education/Exp :-Experience Req. : 11 yrs.18 yrs. Qualification:M.Sc. / M.PharmaResponsibilities1. Hands on Regulatory Affairs-API /DMF Filing/ DMF Compilation/ Submission/ Customer Communication etc.2. Compilation and submission of DMFs...

  • Regulatory Affairs Associate

    1 week ago

    Bengaluru, India Parexel Full time

    As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...

  • Associate Staff Regulatory Affairs Specialist

    2 weeks ago

    Bengaluru, Karnataka, India BD Full time

    Summary This position independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance This position participates on cross-functional teams leads the development of global regulatory strategies authors regulatory submissions leads interactions with regulatory agencies notified bodies reviews design...

  • API Regulatory Affairs

    1 week ago

    Bengaluru, Karnataka, India Biocon Ltd Full time ₹ 15,00,000 - ₹ 20,00,000 per year

    Role - API Regulatory Affairs - DMF Filing/ Compilation (Global market) Level - Associate Manager / Manager Level:- Required Education/Exp :- Experience Req.: 11 yrs. - 18 yrs. Qualification: - M.Sc. / M.Pharma Responsibilities 1. Hands on Regulatory Affairs-API /DMF Filing/ DMF Compilation/ Submission/ Customer Communication etc. 2. Compilation and...