Director, Regulatory Affairs

4 weeks ago

India Friday Plans Full time

Job Description

About Us

Friday Plansis a technology-driven US-based company evolving from a leading online pharmacy into a vertically integrated pharmaceutical company. Our mission is to develop, manufacture, and commercialize our own portfolio of medicines for the US market. We are seeking a seasoned regulatory leader to navigate this journey and build our regulatory function from the ground up.

Position Summary

We are looking for a strategic and hands-on Director of Regulatory Affairs to lead all regulatory activities for our product portfolio targeting the US market. This individual will be responsible for developing and executing the regulatory strategy for our pipeline, from early development through to post-approval life cycle management. You will serve as our primary expert on US FDA regulations, manage the preparation and submission of high-quality regulatory dossiers (ANDAs/NDAs), and act as the primary point of contact with health authorities.

Key Responsibilities

Regulatory Strategy:

- Develop and implement innovative and effective regulatory strategies for the timely approval of our products in the US.
- Provide expert regulatory guidance to cross-functional teams, including R&D, Clinical, and Technical Operations, throughout the product lifecycle.
- Conduct regulatory intelligence and risk assessments to inform product development and company strategy.

Submissions and Dossier Management:

- Lead the planning, authoring, and review of all regulatory submissions, including Investigational New Drug applications (INDs), Abbreviated New Drug Applications (ANDAs), and New Drug Applications (NDAs).
- Ensure all dossiers are high-quality, compliant with eCTD format, and submitted on schedule.
- Manage responses to inquiries and information requests from the US FDA and other regulatory agencies.

Health Authority Interaction:

- Serve as the primary liaison between the company and the US FDA.
- Lead the preparation for and conduct of key meetings with regulatory authorities.

Compliance and Labeling:

- Review and approve all product labeling, advertising, and promotional materials for regulatory compliance.
- Ensure company-wide adherence to cGMP/GCP regulations and internal quality standards.
- Oversee post-approval activities, including annual reports, supplements, and variations.

Cross-Functional Leadership:

- Act as the regulatory subject matter expert on all project teams.
- Review and approve technical documents from our CRO/CMO partners (e.g., validation reports, stability protocols) for regulatory sufficiency.

Qualifications & Experience

Education:A Bachelor's degree in a Life Science is required. An advanced degree (MS, PhD, PharmD) is highly preferred.

Experience:

- A minimum of 12-15+ years of progressive experience in Regulatory Affairs within the pharmaceutical industry.
- Direct, hands-on experience in successfully filing ANDAs and/or NDAs with the US FDA is mandatory.
- Proven track record of leading interactions and negotiations with the FDA.
- Experience managing the regulatory aspects of a product's full lifecycle.

Skills & Expertise:

- Expert knowledge of US FDA regulations, ICH guidelines, and the eCTD submission process.
- Strong strategic thinking with the ability to balance technical, business, and regulatory considerations.
- Exceptional written and verbal communication skills.
- Demonstrated ability to lead and influence cross-functional teams.
- Experience working with India-based manufacturing partners is a significant advantage.

  • Regulatory Affairs Specialist

    3 weeks ago

    Ahmedabad, Gujarat, India, Gujarat Frisch Medical Devices PVT LTD Full time

    Job Title: Regulatory Affairs Junior ManagerLocation: At Ahmedabad Office , Near Thaltej Crossroads Department: RA Reports To: RA Head and Regulatory Department at HO /Director Employment Type: Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday and Saturday Half Day Preferred Gender : M/FExperience: Minimum 2 years Job Summary:We are seeking a...

  • Regulatory Affairs Specialist

    3 weeks ago

    Mumbai, India OrbiTouch HR (orbiTouch outsourcing pvt ltd) Full time

    Job Description Designation : Regulatory Affairs Specialist Qualifications: Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry Experience : Minimum 4 years of experience in regulatory affairs Salary : good hike on current salary Location : Sandhurst Road Mumbai - Head office Essential Duties and Responsibilities: -...

  • Senior Regulatory Affairs Trainer

    3 weeks ago

    Guntur, India Tek Support Full time

    Job Description Job Title: Regulatory Affairs Location: Remote Job type: Part-time Job Summary: We are seeking a highly experienced Regulatory Affairs Trainer with over 10 years of expertise in global regulatory compliance, submissions, and lifecycle management across medical devices, pharmaceuticals, biotech, and FMCG sectors. The trainer will be...

  • Regulatory Affairs Specialist

    4 weeks ago

    Hyderabad, India Weekday (YC W21) Full time

    Job Description This role is for one of our clients Industry: Administrative and Support Services Seniority level: Mid-Senior level Min Experience: 3 years Location: India, Hyderabad JobType: full-time We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to join our team. This role will be responsible for preparing, compiling,...

  • Regulatory Affairs Manager, South Asia

    10 hours ago

    India Align Technology Full time ₹ 84,000 - ₹ 1,80,000 per year

    DescriptionJoin a team that is changing millions of lives.Transforming smiles. Transforming lives. Transforming an industry.At Align Technology, we believe a great smile can transform a person's life, so we create technology that gives people the confidence to take on whatever's next. We revolutionized the orthodontic industry with the introduction of the...

  • Head Regulatory Affairs

    3 weeks ago

    Daman, Diu, India Personnel Search Services Group Full time

    Job Description About the client:PSS has been mandated to hire a Head of Regulatory Affairs for a leading R&D backed, manufacturing women's health organization with operations in over 140 countries worldwide. It is the world's largest manufacturer of Contraceptives devices. Job Purpose The Head of Regulatory Affairs will lead global regulatory strategies for...

  • Assistant Director – International Affairs

    2 weeks ago

    Dehradun, Uttarakhand, India, Uttarakhand DBS Global University Full time

    Assistant Director – International AffairsLocation: DBS Global University, Dehradun (UK)Reports To: Director, International AffairsAbout the RoleWe are seeking a dynamic and experienced professional to join our university as Assistant Director – International Affairs. The role will play a pivotal part in driving our global engagement strategy,...

  • Analyst Regulatory Affair

    2 days ago

    India Dr. Reddy's Laboratories Full time

    Company Description Dr Reddy s Laboratories Ltd is a leading multinational pharmaceutical company based across global locations Each of our 24 000 plus employees comes to work every day for one collective purpose to accelerate access to affordable and innovative medicines because Good Health Can t Wait We started in 1984 with a modest investment 20 employees...

  • Regulatory affairs manager

    2 weeks ago

    Mumbai, Maharashtra, India, Maharashtra SOZIO Full time

    Company :Founded in 1758 in Grasse in the south of France, Maison Sozio is one of the pioneers in fine French perfumery.The history of the Maison Sozio goes back to one of the very first families of perfumers in Grasse, having been at the origin of the community of glove-makers and perfumers.With the integration of Synarome in 2021, Sozio ties back to its...

  • Assistant Manager- Regulatory affairs

    2 weeks ago

    Gurugram, India myGwork - LGBTQ+ Business Community Full time

    Job Description This job is with Johnson & Johnson, an inclusive employer and a member of myGwork the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are...